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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 1,5-diamino-4,8-dihydroxy(4-hydroxyphenyl)anthraquinone and 1,5-diamino-4,8-dihydroxy-2-(4-methoxyphenyl)anthraquinone
EC Number:
943-670-8
Molecular formula:
not applicable
IUPAC Name:
Reaction mass of 1,5-diamino-4,8-dihydroxy(4-hydroxyphenyl)anthraquinone and 1,5-diamino-4,8-dihydroxy-2-(4-methoxyphenyl)anthraquinone
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Himalayan breed- Weight at study initiation: 1.5 - 2 kg- Housing: individual housing in metal cages- Diet (e.g. ad libitum): fed on NAFAG, Gossau SG, rabbit food- Water (e.g. ad libitum): Water ad libitum- Acclimation period: 4 days minimum- Other: Only rabbits showing normal ophthalmic findings were included in the testENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 1- Humidity (%): 55 ± 5- Photoperiod (hrs dark / hrs light): 10 hour light cycle day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
1, 2, 3, 4 and 7 days
Number of animals or in vitro replicates:
6 animals: 3 males and 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): The treated eyes of three female rabbits were each flushed with 10 ml lukewarm water approximately 30 seconds after treatmentTOOL USED TO ASSESS SCORE: - The reactions were appraised with a slit-lamp after 1, 2, 3, 4 and 7 days

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 6/6
Time point:
other: mean 24, 48 and 72 h
Score:
ca. 0
Max. score:
80
Reversibility:
other: No ocular effect oserved
Irritation parameter:
iris score
Basis:
animal: 6/6
Time point:
other: mean 24, 48 and 72 h
Score:
ca. 0
Max. score:
10
Reversibility:
other: No ocular effect oserved
Irritation parameter:
conjunctivae score
Basis:
animal: 6/6
Time point:
other: mean 24, 48 and 72 h
Score:
ca. 0
Max. score:
20
Reversibility:
other: No ocular effect oserved

Any other information on results incl. tables

EYE REACTIONS

Animal Eye 1 d 2 d 3 d 4 d 7 d Mean 1, 2 and 3 d
Cornea
1 M eye not rinsed 0 0 0 0 0 0.0
2 M eye not rinsed 0 0 0 0 0 0.0
3 M eye not rinsed 0 0 0 0 0 0.0
4 F rinsed after 30 sec. 0 0 0 0 0 0.0
5 F rinsed after 30 sec. 0 0 0 0 0 0.0
6 F rinsed after 30 sec. 0 0 0 0 0 0.0
Iris
1 M eye not rinsed 0 0 0 0 0 0.0
2 M eye not rinsed 0 0 0 0 0 0.0
3 M eye not rinsed 0 0 0 0 0 0.0
4 F rinsed after 30 sec. 0 0 0 0 0 0.0
5 F rinsed after 30 sec. 0 0 0 0 0 0.0
6 F rinsed after 30 sec. 0 0 0 0 0 0.0
Conjunctivae
1 M eye not rinsed 0 0 0 0 0 0.0
2 M eye not rinsed 0 0 0 0 0 0.0
3 M eye not rinsed 0 0 0 0 0 0.0
4 F rinsed after 30 sec. 0 0 0 0 0 0.0
5 F rinsed after 30 sec. 0 0 0 0 0 0.0
6 F rinsed after 30 sec. 0 0 0 0 0 0.0

 

EFFECT OF RINSING

R = unrinsed eyes / rinsed eyes = 0.0 / 0

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
Non-eye irritant.
Executive summary:

The eye irritation potential of the test substance was investigated by the slit-lamp procedure on the basis of the 'Appraisal of the safety of chemicals in Food, Drugs and Cosmetics' 1959 of the US Association of Food and Drug officials.

0.1 ml of unchanged test substance was applied to the left eye of 3 male and 3 female New Zealand white rabbits for 30 s. The untreated right eye served as controls. Treated eyes of female rabbits were each flushed with 10 ml lukewarm water approximately 30 s after treatment. Eye reactions were scored at 1 d, 2 d, 3 d, 4 d and 7 d after exposure.

The mean irritation indexes (at 1, 2 and 3 d) for 6 out of 6 (6/6) animals were the following: corneal score = 0 and iris score = 0.

and conjunctivae score = 0.

Therefore, the test substance is a non-eye irritant.