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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:
09.09.1992 to 29.01.1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SILAN GF 91
- Substance type: Alkoxysilane
- Physical state: Liquid
- Stability under test conditions: Room temperature kept away from humidity and light
- Storage condition of test material: No data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, France
- Age at study initiation: Three months
- Weight at study initiation: 2.5± 0.2 kg
- Housing: Individual in stainless steel cages
- Diet (e.g. ad libitum): 150 g/animal/day
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19± 3
- Humidity (%): Minimum 50%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 09.09.1992 To: 29.01.1993

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Eyes not rinsed
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
Six
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: OECD 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Ulceration. Presence of a whitish humour on the side of the lids of the treated eye.
Irritation parameter:
cornea opacity score
Basis:
animal: # 2, 3, 4, 5 and 6
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Ulceration. Presence of a whitish humour on the side of the lids of the treated eye. Varying areas of neovascularisation of the cornea.
Irritation parameter:
iris score
Basis:
animal: all animals
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: Animals 1 reversed between Day 14 and 21, but all others had Grade 1 on Day 21. Circumcorneal injections with/out congestion of the iris. Also some animals had permanent myosis with preservation of the direct photomotor reflex.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Grade 1 on Day 21
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Grade 2 on Day 21
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Grade 2 on Day 21
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Grade 2 on Day 21
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal: 2, 3 and 5
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Grade 1 on Day 21
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Grade 1 on Day 21. Depilation area around the lids of the treated eye.
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Grade 2 on Day 21. Depilation area around the lids of the treated eye.
Irritant / corrosive response data:
Five of the six tested rabbits had effects on the eye that were not reversible in within the 21 day observation period.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are met, Category 1 classification is required according to Regulations (EC) No 1272/2008.
Conclusions:
In an eye irritation study conducted to OECD 405 and to GLP (reliability score 1) N-(3-(trimethoxysilyl)propyl)ethylenediamine caused serious damage to rabbit eyes, with effects that were not fully reversed in five of six during the 21-day observation period.