Registration Dossier

Administrative data

Description of key information

skin:
The test substance was shown to be corrosive to the rabbits' skin.
Eyes:
The test substance was shown to be severely eye irritating to the rabbits' eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study conducted according to OECD Guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1982
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund
- Weight at study initiation: 2.0 - 2-3 kg

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
6
Details on study design:
SCORING SYSTEM:
Erythema/eschar formation as well as edema formation were scored according to a 4-graded scoring system (0-3), respectively.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 / 48 / 72 h
Score:
2.55
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 / 48 / 72 h
Score:
1.72
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
During the observation period, scar formation and detachments of skin as well as hardened skin were observed. Erythema formation had not fully disappeared in all animals at the end of the observation period.
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

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: GLP study, conducted according to EPA FIFRA Guideline
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Version / remarks:
1982
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Mohican Valley Rabbitry, Ohio, USA
- Age at study initiation: young adult
- Weight at study initiation: 2.634-3.104 kg

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL


Duration of treatment / exposure:
single application
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
9
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the treated eyes of 3 rabbits were rinsed for about 1 min, the eyes of the remaining 6 rabbits were not washed out
- Time after start of exposure: 30 seconds

SCORING SYSTEM:
Conjunctiva redness and cornea values were scored on the scale 0-3, chemosis and iris findings were evaluated according to a 5 graded scale (0-4) and a 3 graded scale (0-2).

Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(mean of 6 animals, eyes were not washed out after treatment)
Time point:
other: 24 / 48 / 72 h
Score:
2.27
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(mean of 6 animals, eyes were not washed out after treatment)
Time point:
other: 24 / 48 / 72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(mean of 6 animals, eyes were not washed out after treatment)
Time point:
other: 24 / 48 / 72 h
Score:
2.83
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
(mean of 6 animals, eyes were not washed out after treatment)
Time point:
other: 24 / 48 / 72 h
Score:
1.1
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Irritant / corrosive response data:
The findings were not reversible within the 21-days observation period.
Interpretation of results:
other: severe eye damage
Remarks:
Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

0.5 mL of the test item (40 % active ingredient as an aqueous solution) was applied to 6 New Zealand White rabbits and remained on the skin under semi-occlusive covering for 4 hours. Afterwards, the skin reactions were recorded daily. The mean scores (over all animals) over the time points 24, 48 and 72 h were calculated to assess the irritating potential of the test item. For erythema formation, the mean score of 2.55 (max 3) and for edema formation the mean score of 1.72 (max 3) were determined. Edema disappeared within 8 days, but erythema formation was not reversible within the 14 days observation period. Additionally, hardened skin, skin detachments and scar formation were observed during the observation period. Based on these findings, the test material as well as the active ingredient was determined to be corrosive to the skin. This study was considered as key study.

 

In the supporting study the test material was also tested for its skin irritating property on the skin of six (three male and three female) New Zealand White rabbits. 0.5 mL (active ingredient: 33 % w/w) were applied to the test sites and remained there for an exposure period of 4 hours under semi-occlusion. The animals were observed for signs of skin irritation 4-5, 24, 48 and 72 hours after patch removal and afterwards daily for a period of 14 days. Bodyweights were recorded at the beginning of the study and at study termination, and no effects on bodyweights were found. The mean scores for erythema/eschar and edema formation (calculated from the mean values determined after 24, 48 and 72 h for all animals) were 2.9 (max. score 3) and 2.72 (max. score 4), respectively. In one animal both erythema and edema were not reversible within 14 days. Based on these findings, the test item and the active ingredient were considered to be irritating to skin.

 

Eyes:

In an acute eye irritation study the test material (containing 33 % active ingredient in an aqueous solution) was administered to one eye of 9 New Zealand White rabbits each. 0.1 mL of the test item was applied. The treated eyes of 3 rabbits were rinsed 30 seconds after application. The eyes of the remaining 6 animals were scored for symptoms of irritancy and the mean values over the time points 24 / 48 / 72 h were calculated. For conjunctiva redness, chemosis, cornea and iris the mean scores were calculated to be 2.27, 4, 2.83 and 1.1, respectively. The findings were not reversible within the 21-days observation period and the test material as well as the active ingredient were thus determined to be severely irritating to the rabbits' eyes.


Justification for selection of skin irritation / corrosion endpoint:
reliable study report, sufficient for assessment

Justification for selection of eye irritation endpoint:
reliable study report, sufficient for assessment

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: highly irritating

Justification for classification or non-classification

The available data demonstrate a corrosive property of the test substance to rabbits' skin and it was also shown to be severely eye irritating.

The substance is therefore to be classified as skin corrosive cat. 1B and into eye damage cat. 1 and labelled with H314 (Causes severe skin burns and eye damage) under Regulation (EC) No 1272/2008 (CLP).