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EC number: 259-105-7
CAS number: 54326-11-3
1 Individual Scores and Individual Total Scores
for Ocular Irritation
Rabbit Number and Sex
IPR = 1
Time After Treatment
E = Degree of Opacity
F = Area of Cornea Involved
Score (E x F) x 5
Score (D x 5)
A = Redness
B = Chemosis
C = Discharge
Score (A + B + C) x 2
Irreversible eye effects
An eye irritant Category 1 (irreversible effects on the eye)is a test material that produces:
at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/or
at least in 2 of 3 tested animals a positive response of:
corneal opacity³ 3 and/or
calculated as the mean scores following grading at 24, 48 and 72 hours after instillation of the test material
Reversible eye effects categories
An eye irritant Category 2A (irritating to eyes)is a test material that produces:
corneal opacity³ 1 and/or
iritis³ 1 and/or
conjunctival redness³ 2 and/or
conjunctival oedema (chemosis)³ 2
Calculated as the mean scores following grading at 24, 48 and 72-Hour observations after instillation of the test material, and
which fully reverses within an observation period of normally 21 days
Within this category an eye irritant isconsidered mildlyirritating to eyes (Category 2B)when the effects listed above are fully reversible within 7 days of observation.
Category for irreversible eye
Irreversible effects on the eye
If, when applied to the eye of an animal, a substance produces:
- at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversedwithin an observation periodof normally 21 days;
- at least in 2 of 3 animals, a positive response of:
- cornea opacity³3 and/or
calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.
Category for reversible eye
Irritating to eyes
- at least in 2 of 3 tested animals, a positive response of:
- cornea opacity³1 and/or
- iritis>1, and/or
- conjunctival redness³2 and/or
- conjunctival oedema (chemosis)³2
- calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.
For those substances where there is pronounced variability among animal responses, this information shall be taken into account in determining the classification.
Table 2 Individual
Total Scores and Group MeanScores forOcular Irritation
Individual Total Scores At:
Group Mean Score
and Mean Scores for Cornea, Iris and Conjunctivae
Table 4 Individual
Bodyweights and Bodyweight Changes
Rabbit Numberand Sex
Individual Bodyweight (kg)
Bodyweight Change (kg)
study was performed to assess the irritancy potential of the test
material to the eye of the New Zealand White rabbit. The assessment was
carried out in a GLP-compliant study following OECD
Guidelines for the Testing of Chemicals No. 405 “Acute Eye
Irritation/Corrosion” (adopted 24 April 2002) and Method
B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No.
440/2008 in a proprietary, experimental study (Harlan 2013). The study
is considered reliable and relevant for use for this endpoint.
application of the test material to the non-irrigated eye of two rabbits
produced moderate conjunctival irritation in one treated eye and minimal
conjunctival irritation in the other treated eye one hour after
treatment with minimal conjunctival irritation noted in both treated
eyes at the 24-hour observation. Both treated eyes appeared normal at
the 48-hour observation.
The test material, aluminum,
benzoate C16-18-fatty acids complexes,
produced a maximum group mean score of 7.0 and was classified as a
minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according
to a modified Kay and Calandra classification system. Aluminum,
benzoate C16-18-fatty acids complexesdoes
not meet the criteria for classification according to the Globally
Harmonised System of Classification and Labelling of Chemicals or
according to Regulation (EC) No 1272/2008, relating to the
Classification, Labelling and Packaging of Dangerous Substances.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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