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Toxicological information

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Administrative data

Description of key information

Skin sensitization

The available studies for the test chemicals indicate a possibility that it is not likely to cause any sensitization to skin. Hence, the test chemical can be considered to be not sensitizing to skin. It can be further classified under the category “Not Classified” as per CLP regulation.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Experimental data from various test chemicals
Justification for type of information:
Weight of evidence approach based on the available information from various test chemicals.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
WoE report is based on skin sensitization studies on guinea pig and rabbits.
GLP compliance:
not specified
Type of study:
other: Weight of evidence approach based on the available information from various test chemicals.
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Species:
other: 1.guinea pig 2.rabbits
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available
Route:
intradermal
Vehicle:
peanut oil
Concentration / amount:
5 %
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
peanut oil
Concentration / amount:
75%
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
peanut oil
Concentration / amount:
75%
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Adequacy of challenge:
not specified
No. of animals per dose:
Study 1
10
Study 2
4
Details on study design:
Study 1
Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:2
- Exposure period: No data available
- Test groups:10
- Control group: No data available
- Site: No data available
- Frequency of applications: No data available
- Duration: No data available
- Concentrations: 1st: Induction 5 % intracutaneous
2nd: Induction 75 % occlusive epicutaneous


B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: No data available
- Exposure period: No data available
- Test groups:10
- Control group: No data available
- Site: No data available
- Concentrations:75%
- Evaluation (hr after challenge):
Challenge controls:
No data available
Positive control substance(s):
yes
Remarks:
mercaptobenzothiazole
Reading:
1st reading
Group:
test chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No sensitization reaction observed
Remarks on result:
other: Not sensitizing
Reading:
1st reading
Group:
positive control
No. with + reactions:
9
Total no. in group:
9
Clinical observations:
sensitization reaction observed
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
. Test material produced a slight irritation in 2 to 4 rabbits. But no indications of sensitizing properties were found on challenge treatment after 14 day.
Remarks on result:
other: Not sensitizing
Interpretation of results:
other: Not sensitizing
Conclusions:
Available studies for the test chemical indicate a possibility that it is not likely to cause any sensitization to skin. Hence, the test chemical can be considered to be not sensitizing to skin. It can be further classified under the category “Not Classified” as per CLP regulation.
 
Executive summary:

Various studies have been summarized to determine the ability of the test chemical to cause dermal sensitization in living organisms. These studies include in vivo experimental results on Guinea Pig and rabbits for the test chemical.

Study 1

The skin sensitization study of test material was performed in guinea pig using OECD Guideline 406. The test material mixed with vehicle peanut oil. 10 animals were used in test group whereas 9 animals were used in positive control group. Mercaptobenzothiazole used as positive control. The first Induction given using 5 % concentration of test material via intracutaneous route while in second induction test material in 75% concentration applied occlusive epicutaneous route. The challenge was given using 75% concentration of test material via occlusive epicutaneous route. In positive control group all 9 animals showed sensitization reaction while in test group none of the animals showed positive skin sensitization reaction. Hence test material was considered to be not sensitizing in guinea pig.

Study 2

 The skin sensitization study of test material was performed on 4 rabbits using patch test. Undiluted test material was applied on rabbit’s skin using patch. Test material produced a slight irritation in 2 to 4 rabbits. But no indications of sensitizing properties were found on challenge treatment after 14 day. Hence the test material was considered to be not sensitizing in rabbits.

Available studies for the test chemical indicate a possibility that it is not likely to cause any sensitization to skin. Hence, the test chemical can be considered to be not sensitizing to skin. It can be further classified under the category “Not Classified” as per CLP regulation.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization

Various studies have been summarized to determine the ability of the test chemical to cause dermal sensitization in living organisms. These studies include in vivo experimental results on Guinea Pig and rabbits for the test chemical.

WoE 2:

The skin sensitization study of test material was performed in guinea pig using OECD Guideline 406. The test material mixed with vehicle peanut oil. 10 animals were used in test group whereas 9 animals were used in positive control group. Mercaptobenzothiazole used as positive control. The first Induction given using 5 % concentration of test material via intracutaneous route while in second induction test material in 75% concentration applied occlusive epicutaneous route. The challenge was given using 75% concentration of test material via occlusive epicutaneous route. In positive control group all 9 animals showed sensitization reaction while in test group none of the animals showed positive skin sensitization reaction. Hence test material was considered to be not sensitizing in guinea pig.

WoE 3:

The skin sensitization study of test material was performed on 4 rabbits using patch test. Undiluted test material was applied on rabbit’s skin using patch. Test material produced a slight irritation in 2 to 4 rabbits. But no indications of sensitizing properties were found on challenge treatment after 14 day. Hence the test material was considered to be not sensitizing in rabbits.

Available studies for the test chemical indicate a possibility that it is not likely to cause any sensitization to skin. Hence, the test chemical can be considered to be not sensitizing to skin. It can be further classified under the category “Not Classified” as per CLP regulation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Available studies for the test chemicals indicate a possibility that it is not likely to cause any sensitization to skin. Hence, the test chemical can be considered to be not sensitizing to skin. It can be further classified under the category “Not Classified” as per CLP regulation.