Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus 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:
Weight of evidence approach based on various test chemicals
Justification for type of information:
Weight of evidence approach based on various test chemicals
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: Weight of evidence approach based on various test chemicals
Principles of method if other than guideline:
Weight of evidence approach based on various test chemicals. The study 2,3,4 are number as study 1,2,3
GLP compliance:
not specified
Type of study:
other: Weight of evidence approach based on various test chemicals
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Route:
epicutaneous, occlusive
Vehicle:
other: petroleum jelly
Concentration / amount:
500mg (0.5 g) of the test chemical at a concentration of 30% (w/w) (diluted in petroleum jelly)
Day(s)/duration:
6 h under a closed patch, once a week, for 3 weeks
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
42.8 %
Adequacy of induction:
not specified
Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Concentration / amount:
intradermal - 0.1ml Freund’s complete adjuvant in water,1% w/v test chemical in arachis oil, and Freund’s + 1% w/v test chemical in arachis oil (1:1)
epicutaneous- 0.2 – 0.3 ml 50% w/w test chemical in arachis oil
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: petroleum jelly
Concentration / amount:
0.1 g each of 30%, 10%, 3% in petroleum jelly
Day(s)/duration:
24 h
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
42.8%
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
0.1-0.2 ml 25 and 10% w/w test chemical in arachis oil
Day(s)/duration:
24 h
Adequacy of challenge:
not specified
No. of animals per dose:
1. 10- treatment and 10-control
2. 20
3. 29 test and 10 control
Details on study design:
The data is based on weight of evidence approach based on various test chemicals
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test chemical
No. with + reactions:
0
Clinical observations:
no dermal reactions observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
 
Executive summary:

The skin sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.

A delayed contact hypersensitivity test was conducted on Guinea pigs to evaluate the skin sensitization potential of test chemical under occlusive condition.

Ten animals were used in the treatment group and 10 in the control group. During induction, the test site on the flank was clipped and shaved and 500mg (0.5 g) of the test chemical at a concentration of 30% (w/w) (diluted in petroleum jelly) was applied for 6 h under a closed patch, once a week, for 3 weeks. A control site received only the petroleum jelly.

Two weeks after the last application, 0.1 g each of 30%, 10%, 3%, or the petroleum jelly were applied to the shaved skin and left for 24 h under a closed patch. Skin reactions were scored on a −, ±, +, ++, +++ scale at 24 and 48 h.

None of the treated animal showed any signs of delayed contact hypersensitivity within 48 hours. Thus, the test chemical was considered to be not sensitizing in Guinea pigs.

This is supported by the results of a Buehler test conducted in Dunkin Hartley guinea pigs according to OECD Guideline 406 to evaluate the sensitization potential of the test chemical.

During the test, 20 guinea pigs were used. In induction, the animals were induced dermally at concentration of 42.8 %. After induction animals were challenged dermally at same concentration under occlusive condition.

No known skin reactions were observed at induction as well as at challenge exposure.

The test chemical was considered to be not sensitizing in Buehler test carried out Dunkin Hartley guinea pigs.

These results are supported by the another skin sensitization study performed according to OECD 406 Guidelines to observe the sensitizing efficacy of the test chemical in Dunkin Hartley guinea pigs.

20 Dunkin Hartley guinea pigs in test group and 10 Dunkin Hartley guinea pigs in negative controls were used. Guinea pigs were induced with intradermal injections of 0.1ml Freund’s complete adjuvant in water,1% w/v test chemical in arachis oil, and Freund’s + 1% w/v test chemical in arachis oil (1:1) into three separate sites. After 1 week, a single topical application of 0.2 – 0.3 ml 50% w/w test chemical in arachis oil under occlusion for 48 hours was applied. On day 21 animals were challenged with 0.1-0.2 ml 25 and 10% w/w test chemical in arachis oil.

Since there was no evidence of any skin reaction, the test chemical can be concluded as not sensitizing to guinea pigs.

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus 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:

The skin sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.

A delayed contact hypersensitivity test was conducted on Guinea pigs to evaluate the skin sensitization potential of test chemical under occlusive condition.

Ten animals were used in the treatment group and 10 in the control group. During induction, the test site on the flank was clipped and shaved and 500mg (0.5 g) of the test chemical at a concentration of 30% (w/w) (diluted in petroleum jelly) was applied for 6 h under a closed patch, once a week, for 3 weeks. A control site received only the petroleum jelly.

Two weeks after the last application, 0.1 g each of 30%, 10%, 3%, or the petroleum jelly were applied to the shaved skin and left for 24 h under a closed patch. Skin reactions were scored on a −, ±, +, ++, +++ scale at 24 and 48 h.

None of the treated animal showed any signs of delayed contact hypersensitivity within 48 hours. Thus, the test chemical was considered to be not sensitizing in Guinea pigs.

This is supported by the results of a Buehler test conducted in Dunkin Hartley guinea pigs according to OECD Guideline 406 to evaluate the sensitization potential of the test chemical.

During the test, 20 guinea pigs were used. In induction, the animals were induced dermally at concentration of 42.8 %. After induction animals were challenged dermally at same concentration under occlusive condition.

No known skin reactions were observed at induction as well as at challenge exposure.

The test chemical was considered to be not sensitizing in Buehler test carried out Dunkin Hartley guinea pigs.

These results are supported by the another skin sensitization study performed according to OECD 406 Guidelines to observe the sensitizing efficacy of the test chemical in Dunkin Hartley guinea pigs.

20 Dunkin Hartley guinea pigs in test group and 10 Dunkin Hartley guinea pigs in negative controls were used. Guinea pigs were induced with intradermal injections of 0.1ml Freund’s complete adjuvant in water,1% w/v test chemical in arachis oil, and Freund’s + 1% w/v test chemical in arachis oil (1:1) into three separate sites. After 1 week, a single topical application of 0.2 – 0.3 ml 50% w/w test chemical in arachis oil under occlusion for 48 hours was applied. On day 21 animals were challenged with 0.1-0.2 ml 25 and 10% w/w test chemical in arachis oil.

Since there was no evidence of any skin reaction, the test chemical can be concluded as not sensitizing to guinea pigs.

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus 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

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.