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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

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

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): FAT 40508/A
- Batch No.: Roe TV 1P
- Storage conditions: below 5°C
- Purity: ca. 60%
- Expiration date: December 1997

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Chemisch-pharmazeutische Fabrik, D-88397 Biberach
- Weight at study initiation: 2300-2450g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum standard rabbit pellet - Nafag No.814, Gossau, Switzerland
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: at least 5 days

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

Test system

Vehicle:
not specified
Controls:
no
Amount / concentration applied:
32 mg (equals 0.1mL in volume)
Duration of treatment / exposure:
Up to 7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
The test substance was placed into the conjunctival sac of the left eye of each animal after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. The right eye remained untreated and served as a control. The animals were checked daily for systemic symptoms and mortality. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of the test substance. In order to determine the reversibility of the eye reactions additional evaluations of the ocular reactions were needed in this study. A slit-lamp was used to facilitate the evaluation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
0.66
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 and 72 hours and 7 days
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 and 24 hours
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 and 72 hours and 7 days
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 and 24 hours
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
1.33
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
2
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours
Score:
1.67
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 and 72 hours
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
4
Other effects:
- One animal vocalised upon instillation.
- At the end of the observation period (day 7) the conjunctiva of all animals was slightly stained by the test article. This slight staining of the conjunctiva was considered not to represent any risk of serious damage to the eyes because of its minimal intensity and the fact that no functional relevant parts of the eye were involved. In the course of the physiological regeneration of the conjunctiva such a slight staining will most probably disappear without permanent lesions.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.
Executive summary:

In a GLP compliant eye irritation study, performed according to OECD guideline 405, the test substance (32mg) was placed in the conjunctival sac of the left eye of three New Zealand White rabbits. The eyes were examined for 7 days. A mean cornea score of 1 and 0.66 was observed at 1 hour and 24 hours, respectively. Iris scores observed were 1 at 1 and 24 hours. Chemosis scores were 2, 1.33, and 1 at up to 24, 48 and 72 hours, respectively. Chemosis scores observed were 2, 1.67, and 1 at 1, 24, and up to 72 hours, respectively. The scores observed at the other time points were 0. Although irritation was observed in the eye, this was completely reversible within 7 days. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.