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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 analogue substance
Adequacy of study:
key study
Study period:
Oct. 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
yes
Remarks:
Artificial lighting sequence is 10 hours dark, 14 hours light
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
-
EC Number:
400-320-4
EC Name:
-
Cas Number:
94933-05-8
Molecular formula:
not applicable
IUPAC Name:
Reaction products of diazotised anthranilic acid coupled with resorcinol and diazotised 5-aminonaphthalene-1-sulphonic acid, metallised with Chromium (III) basic sulphate, sodium salts
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Morton Commercial Rabbits, Parsonage Farm, Stansted, Essex, England
- Age at study initiation: 12 to 14 weeks
- Weight at study initiation: 2.44 to 2.70 kg
- Gender: female; nulliparous and non-pregnant
- Housing: individual grid floor cages
- Diet: ad libitum; SQC Standard Rabbit Diet, Special Diets Services Ltd., Stepfield, Witham, Essex, England
- Water: ad libitum (analytical test report demonstrates suitability)
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 21 °C
- Humidity: 48 to 62 %
- Air changes per hour: not specified
- Photoperiod (hrs dark / hrs light): 10/14

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 rabbits (female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: warm water
- Time after start of exposure: 24 h

SCORING SYSTEM: Grading of Ocular Lesions, OECD Guideline for the Testing of Chemicals, Test No. 405: Acute Eye Irritation/Corrosion, 2017
- Irritation scores of each animal at 1, 24, 48 and 72 hours and 7 days were measured.
- The scoring systems found in "Any other information on materials and methods", below, was used to assess eye damage parameters.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No corrosive effects were observed.
Other effects:
COLOURATION
Hair adjacent to the treated sites was stained brown by the test item.

Any other information on results incl. tables

Table 1: Individual conjunctivae, iris and corneal irritation scores.

Animal number and gender  Body weight (kg) Time after treatment Conjunctiva Iris Cornea Score Total score
Redness Chemosis Discharge Opacity Area (a+b+c)×2 d×5 e×f×5
a b c d e f
573F 2.44 1 hour 2 2 1 0 0 0 10 0 0 10
1 day 2 0 0 0 0 0 4 0 0 4
2 days 1 0 0 0 0 0 2 0 0 2
3 days 1 0 0 0 0 0 2 0 0 2
7 days 0 0 0 0 0 0 0 0 0 0
574F 2.70 1 hour 2 2 2 0 0 0 12 0 0 12
1 day 2 0 0 0 0 0 4 0 0 4
2 days 1 0 0 0 0 0 2 0 0 2
3 days 1 0 0 0 0 0 2 0 0 2
7 days 0 0 0 0 0 0 0 0 0 0
575F 2.64 1 hour 2 1 1 0 0 0 8 0 0 8
1 day 2 0 0 0 0 0 4 0 0 4
2 days 1 0 0 0 0 0 2 0 0 2
3 days 1 0 0 0 0 0 2 0 0 2
7 days 0 0 0 0 0 0 0 0 0 0

Table 2: Mean eye irritation scores.

Time after treatment Mean scores
Conjunctiva (max 20) Iris (max 10) Cornea (max 80) Mean total scores (max 110)
1 hour 10.0 0.0 0.0 10.0
1 day 4.0 0.0 0.0 4.0
2 days 2.0 0.0 0.0 2.0
3 days 2.0 0.0 0.0 2.0
7 days 0.0 0.0 0.0 0.0

Applicant's summary and conclusion

Interpretation of results:
other: not classified accoring to the CLP Regulation (EC 1272/2008)
Conclusions:
The test item was not found to be an Eye Irritant or an Eye Corrosive.
Executive summary:

The eye irritation potential of the test item was evaluated in an experimental study comparable to the OECD Guideline 405 (1981). 100 mg of moistened test item was administered to the inside of the lower, left eyelid of three female New Zealand albino rabbits and rinsed with warm water after 24 hours. Animals were monitored for corneal capacity, iritis, conjunctival redness and oedema at 1, 24, 48 and 72 hours and 7 days after the application of the test item. The right eye received no treatment, therefore was considered a negative control.

Mean (24, 48 and 72 hour) conjunctival redness scores were 1.33 in all three animals, however this effect was reversible within 7 days. Corneal opacity, iritis and chemosis scores were 0 at all time points and for all three animals. Slight brown staining of the hair adjacent to the eye was observed. No corrosive effect was observed.

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