Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been conducted in compliance with GLP and according to the OECD guideline 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
32085-79-3
EC Number:
608-700-3
Cas Number:
32085-79-3
IUPAC Name:
32085-79-3

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: approx. 3 months
- Weight at study initiation: 2.2-2.8 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 15%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal served as control
Amount / concentration applied:
100 mg of the test item was administered per eye and tested in three animals.
Duration of treatment / exposure:
Single exposure, no washing
Observation period (in vivo):
1, 24, 48 and 72 hours, 4 and 5 days
Number of animals or in vitro replicates:
3
Details on study design:
The test item was placed in the conjunctival sac of the right eye of each animal after gently pulling the lower Iid away from the eyeball. The Iids were
then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control.
The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48, 72 hours and 4 to 5 days after the
administration. The eye reactions were observed and registered. 24 hours after administration the eyes were treated additionally with fluorescein and
examined.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 5 days
Irritation parameter:
iris score
Basis:
animal: 2-3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 1-3
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 5 days
Irritation parameter:
chemosis score
Basis:
animal:
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritant / corrosive response data:
Corneal opacity was observed in all animals:
animal no. 1: 24 to 72 hours (grade 2) and 1 hour and 4 days after instillation;
animal nos. 2 and 3: 1 hour to 72 hours (grade 1) after instillation.
The fluorescein test performed 24 hours after instillation revealed corneal staining in all animals ( 1/4 of the surface).
Irritation of the iris (grade 1) was observed in animal no. one 24 to 72 hours after instillation.
Conjunctival redness (grade 1) was observed in all animals 24 to 72 hours after instillation, in animal no. 3 from 1 hour after instillation onwards.
Conjunctival chemosis (grade 1) was observed in all animals 24 to 72 hours after instillation.
There were no systemic intolerance reactions. All effects were reversible within 5 days after instillation.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study the test item has to be considered as irritating to the eye in rabbits.
Executive summary:

Based on the results of this study the test item has to be considered as irritating to the eye in rabbits.