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Diss Factsheets

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:
1983-09-26 to 1983-10-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study GLP compliant. No major deviations were identified compared to OECD and EU guidelines followed.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 5601-22-20
- Lot/batch No.: Order No J-175
- Physical state: Clear liquid
- Stability under test conditions: There were no apparent changes in the physical state of the test material during administration
- Other: The purity of the test material is the responsibility of the sponsor

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, PA and Perfection Breeders, Douglassville, PA, USA
- Weight at study initiation: 2 - 3 kg
- Housing: Animals were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum
- Water (e.g. ad libitum): Fresh tap water, suitable for human consumption, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye of treated animals served as the control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Once
Observation period (in vivo):
13 days; eyes examined at 1, 24, 48, and 72 hours and 7, 10, and 13 days after treatment
Number of animals or in vitro replicates:
6 (3 males and 3 females)
Details on study design:
SCORING SYSTEM: Grading of irritation is according to the method of Draize, JH et al, J. Pharm, Exp. Ther. 82:377-390 (1944).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: Day 13
Score:
2.6
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
7 d
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
24 h
Score:
3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Day 13
Score:
3.8
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
7 d
Score:
3.8
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
3.3
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
(opacity and area)
Basis:
mean
Time point:
other: Day 13
Score:
3.9
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Remarks:
(opacity and area)
Basis:
mean
Time point:
7 d
Score:
3.9
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
(opacity and area)
Basis:
mean
Time point:
24 h
Score:
3.6
Max. score:
4
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 13 days
Other effects:
Partial rupture of the globe was observed in 4/6 animals 7-13 days after exposure. Corneal opacity was too severe to allow scoring of iris damage in four animals at one or more times.

Any other information on results incl. tables

Note: in many cases, severe opacity prevented scoring of the iris. Max. duration: 13 h; Max. value for iris score at end of observation period: 2

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Conclusions:
Conjunctival, corneal and iridial effects were still observed at the end of the study. The substance is severely irritating to eyes. The average Draize Score at Day 13 was reported as 105.7.