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Administrative data

Description of key information

skin irritation: none
eye irritation: slight

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: test procedure meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
According to ETAD-Subkomitee für Toxikologie 'Empfohlene Methoden zur toxikologischen Untersuchung von Farbstoffen und Hilfsmitteln'.
Treatment of 3 rabbits on the inner side of the ear for 24 hours under occlusive conditions.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
Duration of treatment / exposure:
24 h
Observation period:
directly after treatment and 48h thereafter
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: inner side of the ear
- Type of wrap if used: no details given
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 0h and 48h
Score:
0

No skin reaction was observed.

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

In a skin irritation study the test material was applied to the inner side of the ear of 3 white rabbits under occlusive conditions. No signs of skin irritation became obvious directly after treatment and 48 hours thereafter. Thus, the test material did not cause skin irritation under the protocol used. According to EU Regulation 1272/2008 no classification for skin irritation is warranted.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: test procedure meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
According to ETAD-Subkomitee für Toxikologie 'Empfohlene Methoden zur toxikologischen Untersuchung von Farbstoffen und Hilfsmitteln'.
The test substance was instilled in one eye of each of 3 rabbits. Observation period was 7 days.
GLP compliance:
no
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Controls:
other: the second eye of each rabbit served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Observation period (in vivo):
1 h, 24 h, 48 h, 72 h and 7 days after treatment
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
3
Remarks on result:
other: 1 h after treatment score 1 for erythema
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 1 h after treatment score 1 for erythema and edema
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean of 24, 48, and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 1 h after treatment score 2 for erythema and score 1 for edema
Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Instillation of the test substance into one eye of each of three rabbits led to slight erythema in two animals. All effects were fully reversible within the observation time of 7 days. Thus, under the conditions of this test the test substance was slightly irritating to the eyes of rabbits. According to EU Regulation 1272/2008 no classification for eye irritation is warranted.

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

Additional information

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

In a skin irritation study the test material was applied to the inner side of the ear of 3 white rabbits under occlusive conditions. No signs of skin irritation became obvious directly after treatment and 48 hours thereafter. Thus, the test material did not cause skin irritation under the protocol used. According to EU Regulation 1272/2008 no classification for skin irritation is warranted.

Instillation of the test substance into one eye of each of three rabbits led to slight erythema in two animals. All effects were fully reversible within the observation time of 7 days. Thus, under the conditions of this test the test substance was slightly irritating to the eyes of rabbits. According to EU Regulation 1272/2008 no classification for eye irritation is warranted.