Registration Dossier

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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Sex: Females, nulliparous and non-pregnant
Acclimatisation period: At least 10 days
Age and weight range: 9 to 11 weeks old, approximately 2 kg
Housing: Polycarbonate/stainless steel cages measuring 65.3x65.3x45 cm with perforated NorylTM floor suspended over trays
Water supply: ad libitum
Diet: STANRAB (P) SQC, Special Diets Services, Witham, Essex CM8 3AD, UK
Diet supply: ad libitum throughout the study
Room lighting: Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
Air changes: Approximately 15 to 20 air changes per hour
Temperature range: 19°C ± 2°C
Relative humidity range: 55% ± 15%

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: For each animal, one eye was treated and the other one remained untreated (control eye)
Amount / concentration applied:
0.1ml
Duration of treatment / exposure:
Frequency of treatment: once only, on the day of dosing (Day 1)
Observation period (in vivo):

Approximately 1, 24, 48 and 72 hours after treatment.
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72h
Score:
ca. 0
Max. score:
0
Reversibility:
not specified
Irritant / corrosive response data:
No irritation at either the conjunctivae, iris or cornea (score of 0) was recorded in any treated animal during the whole observation period (72 hours).
Other effects:
There was no indication of a systemic effect.
On dosing, excessive blinking of the treated eye was observed in all animals. No signs of pain or distress were observed in the remaining sessions performed during the study.
Changes in body weight, seen during the course of the study, were not remarkable.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No irritation at either the conjunctivae, iris or cornea (score of 0) was recorded in any treated animal during the whole observation period (72 hours).