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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:
From October 28 to November 4, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1992
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
albino

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
28.2 mg ± 1.0 mg (ca. 0.1 ml)
Duration of treatment / exposure:
Single exposure; not removed
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
- 2 % fluorescein in water was applied 24 hours after application in order to determine corneal epithelial damage. After readings for % damaged area were taken, the eye was rinsed with ca. 50 ml tepid tap water to remove substance.
- Observations: mortality (twice daily), toxicity (daily), body weight (study commencement), irritation parameters (24, 48 and 72 hours after application): corneal opacity, area of corneal irritation, iritis, conjunctival irritation (redness, chemosis, discharge)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal: #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: #1, #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
- Slight dulling of the normal lustre of the cornea (score = 0) and epithelial damage (10 % on 35 % of the corneal area) were observed in animals #1 and #3 only, 24 hours after application only.
- Iridic irritation was observed in animal #2 only, 1 hour after application, and in animal #1 only at 24 hours after application.
- Conjunctival irritation of redness, chemosis and discharge had completely resolved within 7 days in all animals.
- No evidence of corrosion or systemic toxicity were apparent.
Other effects:
- Remnants of the test item in the eye: all three animals at 1 hour and 24 hours after application; additionally, animal #2 at 48 hours after application. These remnants were not removed with rinsing after 24 hour interval reading.
- Purple staining of the fur on the head and paws, caused by the test item: all three animals at 1 hour and 24 hours after application.
- Haemorrhage in the sclera of the eye, where remnants of the test item had been noted previously: animal #2 at 72 hours.

Applicant's summary and conclusion

Interpretation of results:
other: cat. 2 eye irritant according to the CLP Regulation (EC 1272/2008)
Conclusions:
Irritating to eyes.