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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was performed between 02 June 2008 and 12 June 2008.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from stanadrd 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:
2008
Report date:
2008

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:
UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994)). Date of inspection: 21/08/2007. Date of signature: 17/07/2008.

Test material

Constituent 1
Details on test material:
Sponsor's identification :Hatcol 1760
Description : clear colourless slightly viscous liquid
Date received : 04 February 2008
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: Harlan UK Limited, Bicester, Oxon, UK.
- Age at study initiation: twelve to twenty weeks old.
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: The animals were individually housed in suspended cages.
- Diet: Certified Rabbit Diet - ad libitum
- Water: ad libitum
- Acclimation period: 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): and the 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): 0.1 ml
- 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:
3: 1 animal for initial assessment followed by 2 further animals.
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
CLASSIFICATION: EU


TOOL USED TO ASSESS SCORE:standard opthalmascope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
degree of opacity
Basis:
animal: 67553 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
cornea opacity score
Remarks:
Degree of opacity
Basis:
animal: 67565 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
cornea opacity score
Remarks:
Degree of opacity
Basis:
animal: 67567 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal: 67553 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal: 67565 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal: 67567 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 67553 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score of 2 observed at 1 hr
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 67565 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score of 2 observed at 1 hr
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 67567 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 24 hrs
Remarks on result:
other: Score of 2 observed at 1 hr
Irritation parameter:
chemosis score
Basis:
animal: 67553 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score of 2 observed at 1 hr
Irritation parameter:
chemosis score
Basis:
animal: 37565 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 24 hrs
Remarks on result:
other: Score of 2 observed at 1 hr
Irritation parameter:
chemosis score
Basis:
animal: 67567 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 24 hrs
Remarks on result:
other: Score of 2 observed at 1 hr
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24-hour observation.
All treated eyes appeared normal at the 48-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)

Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004/73/EC

Result. A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. All treated eyes appeared normal at the 48‑hour observation.

Conclusion.  The test material did not produce positive criteria in any rabbit according to the EU (99/45/EEC) labelling regulations. No symbol and risk phrases are therefore required.