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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:
29 November 1989 to 20 December 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1987)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): DYNASYLAN 1110; N-Methyl-3-aminopropyl-trimethoxysilane
- Physical state: colourless to light yellow liquid
- Odour: amine-like
- Density: 0.98 g/cm³
- Melting point: 210°C
- Flash point: 82°C
- ph value: approximately 12.3
- Storage condition of test material: protected from humidity
- Date of receipt: 18 September 1989

Test animals / tissue source

Species:
rabbit
Strain:
other: Small White Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Strain: Small White Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH (Biberbach, Germany)
- Weight at study initiation: 2.2 kg
- Housing: individually in a stainless steel cage
- Diet: K4 Alleindiät for Rabbits (Ssniff Spezialfutter GmbH, 4770 Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1
- Humidity (%): 60±5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml
Duration of treatment / exposure:
24 h
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
1 male
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: Draize Scoring System

TOOL USED TO ASSESS SCORE: fluorescein

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:
not reversible
Remarks:
within 21 days
Remarks on result:
other: Opacity was observed for an area greater than three quarters up to the whole area.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks:
within 21 days
Remarks on result:
other: The iris was observed to be strongly reddened with haemorrhage. Delayed iris reaction was noted until day 6 post-treatment, and circumcorneal injection occurred on day 6 and persisted until study termination.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
within 21 days
Remarks on result:
other: Necrosis and haemorrhage of the nictitating membrane and the conjunctiva was noted after 24 h until day 6 post-treatment.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Other effects:
No further effects were stated in the study report.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are met, Categroy 1 (irreversible effects on the eye) classification required according to Regulations (EC) No 1272/2008
Conclusions:
The test item was tested in one rabbit for primary eye irritation/corrosion according to the OECD TG 405 (1987), but not in compliance with GLP. The instillation of the test material resulted in irreversible effects on the cornea, iris, and conjunctivae. Hence, the test item has to be classified as irreversible effects on the eye (Cat 1) according to EC/1272/2008.