Registration Dossier

Administrative data

Description of key information

Skin irritation (rabbit): not irritant

Eye irritation (rabbit): not irritant

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
Study period:
30 Aug - 10 Sep 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
The test method used is in fact the Draize test method.
GLP compliance:
yes
Test material information:
Composition 1
Specific details on test material used for the study:
- Name of test material (as cited in study report): Sumilizer GM
- Analytical purity: >99%
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shizuoka Agricultural Cooperative Association for Laboratory Animals, Shizuoka, Japan
- Weight at study initiation: 2.74 - 3.19 kg
- Housing: in fixing boxes during treatment period
- Diet, CG-3 type (Clea Japan Inc., Osaka, Japan), approx. 100 g/day
- Water: ad libitum, except for a period of 24 h after application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 2
- Humidity (%): 60 ± 10
Type of coverage:
occlusive
Preparation of test site:
other:
Remarks:
clipped and abraded
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g moistened with physiological saline
Duration of treatment / exposure:
24 h
Observation period:
7 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: skin of the back
- Type of wrap if used: The test material was applied to 1 inch square lint patches The patches were held in place with an occlusive tape (Blenderm, surgical tape, 3M Co.).

REMOVAL OF TEST SUBSTANCE
- Washing: Treated skin was wiped to remove remaining test substance.
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
24, 48 and 72 h and 7 days

SCORING SYSTEM:
- Method of calculation: Draize scoring system
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No skin reaction was observed on abraded and clipped skin.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
Conclusions:
CLP: not classified
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
Study period:
10 Feb - 28 Mar 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted Oct 2012
Deviations:
yes
Remarks:
no topical anesthetics and systemic analgesics were used; no initial test was performed
GLP compliance:
no
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Nihon Dobutsu Co., Osaka, Japan
- Weight at study initiation: 2.35 - 2.68 kg
- Diet: CG-3 type (Clea Japan Inc., Osaka, Japan), 100 g/day
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 2
- Humidity (%): 60 ± 10
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg
Duration of treatment / exposure:
Group 1: Single application without washing
Group 2: 30 s
Observation period (in vivo):
1, 24, 48, 72 and 96 h and 7 days
Number of animals or in vitro replicates:
6 (Group 1) and 3 (Group 2)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The treated eyes of the animals in Group 2 were rinsed with lukewarm water
- Time after start of exposure: 30 s (Group 2); the treated eye remained unwashed following the instillation (Group 1)

SCORING SYSTEM: Draize scoring system
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: unwashed
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: unwashed
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: unwashed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: unwashed
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: washed
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: washed
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: washed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: washed
Irritant / corrosive response data:
All animals showed no conjunctival redness and swelling resulting in a mean score of 0 for both endpoints over 24, 48 and 72 h, respectively. The cornea opacity and iris score were also graded with scores of 0 over 24, 48 and 72 h, respectively.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008.
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The skin irritancy potential of the test substance (CAS 61167-58-6) was determined in a skin irritation study performed similar to OECD guideline 404 (Laboratory of Biochemistry and Toxicology Research, 1982). The test substance was topically applied to the clipped skin of three male and three female rabbits (NZW) for 24 h. Local reactions were scored at 24, 48 and 72 h and 7 days using the Draize scheme after substance application. No skin irritant reactions were observed in all animals (graded with score 0 for erythema and edema) at 24, 48 and 72 h and at 7 days reading time points. Based on the results of the conducted study, the test substance (CAS 61167-58-6) is not considered to exhibit irritating properties towards the skin.

 

Eye irritation

To evaluate the irritation potential of the test substance (CAS 61167-58-6) towards the eyes, an in vivo study performed similar to OECD guideline 405 was evaluated. In this study, 100 mg (unchanged) of the test substance was instilled into the eyes of 9 white rabbits (NZW) (Laboratory of Biochemistry and Toxicology Research, 1982). In Group 1, comprising 6 animals, the treated eyes remained unwashed. The eyes of the 3 animals of Group 2 were rinsed 30 s after the application of the test substance with lukewarm water. The eyes were examined 1, 24, 48, 72, 96 and 168 h after treatment. Scoring of eye findings was done according to the Draize scoring system. All animals showed no conjunctival redness and swelling resulting in a mean score of 0 for both endpoints over 24, 48 and 72 h, respectively. The cornea opacity and iris score were also graded with scores of 0 over 24, 48 and 72 h, respectively. Based on the results of the conducted study, the substance (CAS 61167-58-6) is considered as not irritating towards the eyes.

Justification for classification or non-classification

The available data on skin and eye irritation / corrosion with the test substance (CAS 61167-58-6) do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification.