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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 July - 15 July 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed in accordance with OECD and GLP guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Animal specifics: Hoechst AG, conventional breed
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 2 months to 5 months
- Weight at study initiation: 2.9 kg to 3.2 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2013) ad libitum
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 2°C (air-condition)
- Humidity (%): 55±10%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
other: polyethyleneglycol 400
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
One administration 24 hours
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
3
Details on study design:
Application of the substance to the conjunctival sac of the left eye of each animal, the right eyes served as control respectively

REMOVAL OF TEST SUBSTANCE
- Washing: Washing with physiological saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24, 48 and 72 h after administration) took place
- Time after start of exposure: see above

TOOL USED TO ASSESS SCORE: 0.01 % solution of fluorescein sodium, under UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of three animals
Time point:
other: after 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since on effects occured
Irritation parameter:
iris score
Basis:
mean
Remarks:
of three animals
Time point:
other: after 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of three animals
Time point:
other: after 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: grade 1 chemosis was observed in all animals at 1 hour and was fully reversible within 24 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of three animals
Time point:
other: after 24, 48 and 72 hours
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
The score refers to redness of conjunctiva, which was evident in all animals 1 h after treatment (score 1 in all 3 animals). The value of 0.11 is the mean (of the three assessments at 24, 48 and 72 h) for all animals combined as well as for each individual animal. At 48 and 72 h, this score was 0 in all animals. Other parameters examined (opacity of cornea, iris, chemosis of conjunctiva) showed scores of 0 at the relevant time points.
Other effects:
Red staining of eye discharge was observed at 1 hour after application.

Applicant's summary and conclusion

Conclusions:
67/548/EEC: Eye irritation: no classification warranted
1272/2008/EC: Eye irritation: no classification warranted

In a OECD guideline and GLP compliant primary eye irritation test in rabbits, Test item (Pigment Red 112) caused grade 1 (1/3 animals) chemosis after one hour and conjunctival reddening grade 1 (3/3 animals) after 1 hours and grade 1 (1/3 animals) after 24 hours. No effects were observed for these and other parameters at the other reading times up to 72 hours. Therefore, Test item (Pigment Red 112) was regarded as not eye irritating.