>  Topics > GHS > GHS Classification

GHS

GHS Classification Criteria for Eye Irritation and Serious Eye Damage

Little Pro on 2018-03-06

Substances that cause adverse changes at the site of first contact (skin, eye, mucous membrane, respiratory tract etc) after a single exposure can be categorised as irritant or corrosive substances, depending on the reversibility of the effects observed. Eye irritation is the production of changes in the eye following application of a test substance to the front outer surface of the eye, which is fully reversible within 21 days. Serious eye damage is the production of tissue damage in the eye, or serious physical decay of vision, following the application of a test substance to the front outer surface of the eye, which is not fully reversible within 21 days.

Hazard Categories for Eye Irritation and GHS Classification Criteria

There are 3 hazard categories for eye irritation under GHS. The table below summarizes eye irritation classification criteria for substances and tested mixtures.

Category GHS Classification Criteria

 Category 1 (Causes serious eye damage) 

  • Classification as corrosive to skin; 
  • Human experience or data showing damage to the eye which is not fully reversible within 21 days; 
  • Structure/activity or structure property relationship to a substance or mixture already classified as corrosive; 
  • pH extremes of < 2 and > 11.5 including buffering capacity; 
  • Positive results in a valid and accepted in vitro test to assess serious damage to eyes; or 
  • Animal experience or test data that the substance or mixture produces either (1) in at least one animal, effects on the cornea, iris or conjunctiva that are not expected to reverse or have not reversed; or (2) in at least 2 of 3 tested animals a positive response of corneal opacity ≥ 3 and/or iritis > 1.5, calculated as the mean scores, following grading at 24, 48, and 72 hours 

 Category 2A (Irritant)

  • Classification as severe skin irritant; 
  • Human experience or data showing production of changes in the eye which are fully reversible within 21 days; 
  • Structure/activity or structure property relationship to a substance or mixture already classified as an eye irritant; 
  • Positive results in a valid and accepted in vitro eye irritation test; or 
  • Animal experience or test data that indicate that the substance/mixture produces a positive response in at least 2 of 3 tested animals of: corneal opacity ≥ 1, iritis ≥ 1, or conjunctival edema (chemosis) ≥ 2, calculated as the mean scores, following grading at 24, 48, and 72 hours  and the effects are reversible within 21 days.

 Category 2B (Mild irritant)

  • Human experience or data showing production of mild eye irritation;
  • If a substance meets classification criteria for 2A and such effects can be reversible within <strong>7 days, </strong>the substance can be classified as 2B.

Eye Irritation Classification Criteria for Mixture

If a mixture contains a hazardous ingredient or multiple ingredients that have been classified as damaging to eyes or eye irritant, the mixture will be classified based on the table below. 

 GHS Classification Criteria Eye Irritation

It should be noted that certain chemicals such as acids, bases, inorganic salts, aldehydes, phenols and surfactants may not be classified using above additivity approach. For those chemicals, you may refer to the non-additivity approach below. 

Eye irritation GHS classification pH

Examples of Eye Irritation Classification

References and More Reading

Having Questions?

We do not provide consultancy services. If you have questions or need any help, please contact our sponsor. You may also find an expert in CSP business directory below. If you are a consultant, you may get yourself listed in CSP business directory (free) or sponsor this page to leave your contact info on this page..

 Tags: Topics - GHSGHS Classification