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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:
Feb/Mar 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study. No GLP compliance is claimed. However, auditation and quality assurance inspections of the final report were performed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Remarks:
Auditation and quality assurance inspections of the final report were performed.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Lesser's Rabbitry, Union Grove, WI
- Weight at study initiation: 2.6 to 3.1 kg
- Fasting period before study: No
- Housing: Individually housed in stainless steel cages (61.0 x 45.5 x 42.0 cm)
- Diet: Rabbits were fed Purina Rabbit Chow Complete Blend (Ralston Purina Co.) ad libitum
- Water: ad libitum
- Acclimation period: approx. 25 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 22
- Humidity (%): approx. 40 (relative)
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES:
1981-02-16 - 1981-03-02

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Each animal had one treated eye (right eye) and one untreated eye (left eye) which served as the control.
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
The test article was instilled into the everted lower lid of the right eye of each rabbit and allowed to remain there.
Observation period (in vivo):
14 days, with ocular examinations on day 1, 2, 3, 4, 7 and 14 following test material administration.
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
SCORING SYSTEM: Draize method
TOOL USED TO ASSESS SCORE: fluorescein and ultraviolet light

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 2, 3, 4, 7, 14 d
Score:
0
Max. score:
0
Irritant / corrosive response data:
Eye irritation was not observed in any animal at any time point.
Other effects:
No other effects described.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test report describes a valid guideline study. Auditation and quality assurance inspections of the final report were performed. The test substance was not irritating to the rabbit eye under the conditions of the study and is thus not classified.
Executive summary:

An eye irritation study was conducted using a similar procedure to that described in the current OECD Guideline 405 (Reckers, 1981). The test material (CAS No. 91648-65-6) was applied at a volume of 0.1 mL to the right eye of six rabbits (strain: New Zealand White). The test article was left in the eye (i.e. no rinsing was performed) and the rabbits were observed during application followed by a 14 -day observation period. The left eye served as control.

The treated eye was scored at day 1, 2, 3, 4, 7 and 14 following instillation. Ocular irritation was not observed in any animal during the study.