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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
July 14, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.42
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
NZW Albino Rabbits
Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal
Food: mümmel Z ad libitum
Supplier: sniff Spezialdiaten GmbH, Soest/Westfal
Water: Tap water ad libitum
Single housing
Weight: mean 2.5 kg

ENVIRONMENTAL CONDITIONS
- Temperature: 16-18°C
- Humidity: approx. 40 %
- Lighting time: 12 hours daily

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 µL bulk volume
Duration of treatment / exposure:
24 hours
no rinsing after treatment period
Observation period (in vivo):
The eyes were examined 24, 48, 72 hours, and 8 days after application of the test substance.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:

TOOL USED TO ASSESS SCORE: opthalmoscope
on day 8: fluorescein; investigation under UV light or conalt blue filter after instillation of one drop of fluorescein-sodium solution and rinsing with physiological saline


SCORING SYSTEM: Draize

Evaluation
Evaluation covered pathological findings in the cornea (degree of opacity and area •affected), iris and conjunctivae (reddening, swelling and discharge). Evaluation details were based on the key given below, which was used to determine the irritation score.

Assessment key
From : The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, 1959, p.51 (see below)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
other: Lacrimation
Basis:
mean
Time point:
24/48/72 h
Score:
0.75
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24/48/72 h
Score:
1.7
Max. score:
110

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Testing for primary eye irritation in the rabbit showed that the substance is not irritating to eyes.
Executive summary:

Method

The substance was tested for its eye irritation potential according to the Code of Federal Regulations, Title 16, Section 1500.42

100 µL of the test item was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control. The treated eyes were examined 24, 48 and 72 hours and 8 days after application of the test substance. At 8 days the eyes were also examined for corneal lesions under UV light after instillation of one drop of fluorescein.

Results

No irritant effects were observed, hence the test substance is considered to be not irritating to the eye.