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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 November 2000 to 03 December 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

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)
Remarks:
Date of inspection: February 28th 2000 Date of signature: April 26th 2000

Test material

Constituent 1
Details on test material:
Sponsor's identification :S178207
Description : white powder
Batch number : SBT-5-0254
Date received : 08 November 2000
Storage conditions :room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: twelve to sixteen weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: animals were individually housed in suspended metal cages
- Diet: ad libitum - STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK
- Water: e.g. ad libitum - mains drinking water
- Acclimation period: acclimatisation period of at least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness


IN-LIFE DATES: From: Day of dosing (Day 0) To: Day of sacrifice (Day 7)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 ml of the test material, which was found to weigh approximately 35 mg (as measured by gently compacting the required volume into an adapted syringe)
- Concentration (if solution): not applicable


VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not stated in report
- Time after start of exposure: not stated in report


SCORING SYSTEM: Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49


TOOL USED TO ASSESS SCORE:standard opthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
Degree of opacity
Basis:
animal: 145 Female
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritation parameter:
cornea opacity score
Remarks:
Degree of opacity
Basis:
animal: 178 Female
Time point:
other: Mean of 24,48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritation parameter:
cornea opacity score
Remarks:
Degree of opacity
Basis:
animal: 179 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritation parameter:
iris score
Basis:
animal: 145 Female
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal: 178 Female
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritation parameter:
iris score
Basis:
animal: 179 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 145 Female
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed at 24, 48 and 72 hours
Remarks on result:
other: Score of 1 at 1 hour, fully reversed at 24 hrs
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 178 Female
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed at 24, 48 and 72 hours
Remarks on result:
other: Score of 1 at 1 hour, fully reversed at 24 hrs
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 179 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed at 24, 48 and 72 hours
Remarks on result:
other: Score of 1 at 1 hour, fully reversed at 24 hrs
Irritation parameter:
chemosis score
Basis:
animal: 145 Female
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
chemosis score
Basis:
animal: 178 Female
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritation parameter:
chemosis score
Basis:
animal: 179 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritant / corrosive response data:
Very slight conjunctival irritation was noted in all treated eyes at the 1-hour observation. All treated eyes appeared normal at the 24-hour observation.
Other effects:
None noted

Any other information on results incl. tables

The test material did not produce positive criteria in any rabbit according to the EU labelling regulations. No symbol and risk phrases are therefore required.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material did not produce positive criteria in any rabbit according to the EU labelling regulations. No symbol and risk phrases are therefore required.
Executive summary:

Introduction. 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 February 1987)

§        Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation)

Result. A single application of the test material to the non-irrigated eye of three rabbits produced very slight conjunctival irritation in all treated eyes at the 1-hour observation. No other ocular reactions were noted during the study.

Conclusion. The test material produced a maximum group mean score of 2.0 and was classified as practically non-irritating (Class 2 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 93/21/EEC.