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Diss Factsheets

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 2010
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
The number of animal is not enough to let a correct classification according to CLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

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

Test material

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Hillcrest, Belton, Loughborough, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.40 or 2.42 kg
- Housing: individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum to 2030 Teklad global rabbit diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 degrees C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 / 12 dark-light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml
Duration of treatment / exposure:
Test material was applied to eye, and the eyelids were held together for about 1 second and then released. Eyes were not rinsed after exposure.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE: Eyes were not rinsed after exposure.

SCORING SYSTEM: initial pain reaction from 6-point scale, Draize scale for scoring ocular irritation was used during the observation period. After scores were assigned, a modified version of Kay and Calandra (1962) was used to classify the ocular irritancy potential.

TOOL USED TO ASSESS SCORE: ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
12
Reversibility:
not specified
Remarks on result:
other: Both test animals had scores of 12 at 1 hour, which had diminished to 6 at 24 hours. Both had a score of 0 at 48 and 72 hours.
Irritation parameter:
cornea opacity score
Basis:
animal: #69221, #69235
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #69221, #69235
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #69221
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal: #69235
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal: #69221, #69235
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Other effects:
Body weight changes after 3 days: +0.05 kg

Any other information on results incl. tables

Table. Individual Scores and Individual Total Scores for Ocular Irritation

Rabbit number and sex

69221 Male

69239 Male

Time after treatment

1 hour

24 hours

48 hours

72 hours

1 hour

24 hours

48 hours

72 hours

Cornea

 E = Degree of opacity

0

0

0

0

0

0

0

0

 F = Area of Cornea involved

0

0

0

0

0

0

0

0

 Score (E x F) x 5

0

0

0

0

0

0

0

0

Iris

 D

0

0

0

0

0

0

0

0

 Score (D x 5)

0

0

0

0

0

0

0

0

Conjunctivae

 A = Redness

2

1

1

0

2

1

0

0

 B = Chemosis

2

1

0

0

2

1

0

0

 C = Discharge

2

1

0

0

2

1

0

0

 Score (A + B + C) x 2

12

6

2

0

12

6

0

0

Total Score

12

6

2

0

12

6

0

0

 

 

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
The number of animal is not enough to let a correct classification according to CLP Regulation
Conclusions:
The test material does not seem to be an eye irritant under the test conditions
Executive summary:

The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

-      OECD guidelines for the testing of chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002)

-      Method B.5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008

 

A single application of the test material to the non-irrigated eye of two rabbits produced moderate conjuctival irritation. Both treated eyes appeared normal at the 48 -Hour observation.

 

The test material does not seem to be an eye irritant based on the scores obtained for conjuctivae redness, chemosis, cornea and iris.