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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Skin irritation: the key study found no evidence of irritant action when the test substance was applied to rabbit skin.  This finding was supported by a separate study using an aqueous 50% solution of test material: again no significant evidence of irritation was seen.
Eye irritation: the key study found clear evidence of irritation when the test substance was instilled into the rabbit eye. This finding is supported by a separate study using an aqueous 50% solution test material: although recorded responses were less, 3/6 test animals showed changes clearly indicative of irritant activity (24-48-72h mean conjunctival effect scores >2).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported study performed under GLP and using a standard test method.
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Bodyweight 2.2-2.6 kg and checked for absence of corneal, iridial or conjunctival abnormalities pre-test.
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
67 mg (0.1 ml equivalent)
Duration of treatment / exposure:
3 rabbits: no removal of test substance up to 14 days post-treatment.
1 rabbit: treated eye washed with distilled water 30 seconds after treatment.
Observation period (in vivo):
Up to day 14 post-treatment.
Number of animals or in vitro replicates:
3 + 1
Details on study design:
One eye treated/animal: untreated eyes served as controls.
Irritation parameter:
cornea opacity score
Remarks:
: corneal opacity
Basis:
animal #1
Remarks:
mean score
Time point:
other: Across 24, 48, and 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Score 2 also at 1h
Irritation parameter:
cornea opacity score
Remarks:
: corneal opacity
Basis:
animal #2
Remarks:
mean score
Time point:
other: Across 24, 48 and 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Score 2 also at 1h
Irritation parameter:
cornea opacity score
Remarks:
: corneal opacity
Basis:
animal #3
Remarks:
mean score
Time point:
other: Across 24, 48 and 72h
Score:
0
Max. score:
0
Remarks on result:
other: Score 0 also at 1h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean score
Time point:
other: Across 24, 48 and 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Score 2 also at 1h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean score
Time point:
other: Across 24, 48 and 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Score 2 also at 1h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean score
Time point:
other: Across 24, 48 and 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Also score 2 at 1h
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score
Time point:
other: Across 24, 48 and 72h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Score 3 at 1h
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean score
Time point:
other: Across 24, 48 and 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Also score 2 at 1h
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean score
Time point:
other: Across 24, 48 and 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Also score 2 at 1h
Irritant / corrosive response data:
Iridial changes were less marked that those tabulated above:
- animal 1, score 1 at 24h only
- animal 2, score 1 at 48 and 72h only
- animal 3, score 0 only.

In the one additional animal eyewashed 30 seconds after treatment, no corneal or iridial changes were observed but conjunctival redness and discharge scores were 2 up to 72h (fully recovered by Day 14).
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this study, eye irritation was evident. All lesions were reversible, but the responses were sufficient to trigger classification under the CLP Regulation.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
The test substance did not irritate rabbit skin.

Justification for selection of eye irritation endpoint:
The test substance caused corneal and conjunctival changes which were reversible but clearly indicated irritation.

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin irritation: when both the test substance itself and an aqueous 50% solution were tested, no significant local reactions were seen. Hence no classification in respect of skin irritation is warranted.

Eye irritation: in the key study, mean scores sufficient to warrant classification as irritating to eyes were seen:

- corneal opacity score 2 in 2/3 test animals

- conjunctival redness score 2 in 3/3 test animals

- chemosis =/>2 in 3/3 test animals.

Accordingly, classification as irritating to eyes, Eye Irritant 2; H319 under the CLP Regulation (1272/2008, as amended) is appropriate.