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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: Weight of evidence approach based on test chemicals
Principles of method if other than guideline:
Weight of evidence approach based on test chemicals
GLP compliance:
not specified
Type of study:
other: Weight of evidence approach based on test chemicals
Species:
guinea pig
Strain:
other: Albino, Hartley
Sex:
male/female
Route:
intradermal
Vehicle:
not specified
Concentration / amount:
0.1 mL at 2.5 X 0.5%(ICC) : 10 guinea pigs
Adequacy of induction:
other: The concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC).
Route:
epicutaneous, open
Vehicle:
not specified
Adequacy of induction:
not specified
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
10% solution
Adequacy of induction:
not specified
No.:
#1
Route:
intradermal
Vehicle:
not specified
Concentration / amount:
Challenge concentration: 0.1 mL at 0. 25% (ICC) and 20% (ACC): 10 guinea pigs
Re- challenge concentration: 0.1 mL at 0.25%(ICC) and 20% (ACC): 10 guinea pigs
Day(s)/duration:
24 hours
Adequacy of challenge:
other: The concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC). The highest concentration which caused no irritation was selected as the application challenge concentration (ACC).
No.:
#1
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
Challenge concentration: 0.1 mL at 0. 5% (ICC) and 10% (ACC): 10 guinea pigs
Re- challenge concentration: 0.1 mL at 0.5%(ICC) and 10% (ACC): 10 guinea pigs
Day(s)/duration:
24 hours
Adequacy of challenge:
other: The concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC). The highest concentration which caused no irritation was selected as the application challenge concentration (ACC).
No.:
#1
Route:
epicutaneous, open
Vehicle:
not specified
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
1 or 2% solutions
Adequacy of challenge:
not specified
No. of animals per dose:
1. 10 guinea pigs
2. no data available
3. no data available
Details on study design:
The data is based on weight of evidence approach based on various test chemicals
Challenge controls:
no data available
Reading:
1st reading
Group:
test chemical
No. with + reactions:
0
Clinical observations:
no signs of sensitization available
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:

Based on the available studies for the various test chemicals, the weight of evidence approach was applied to assess the dermal sensitization potential for the test chemical.

Modified Draize Technique was employed to determine the concentrations suitable for sensitization testing [injection challenge concentration(ICC) and application challenge concentration ( ACC) ] of the test chemical.

Hartley strain albino guinea pigs bred were used for the study. Four guinea pigs of same sex were used for the preliminary irritation study and 10 guinea pigs were used for the main sensitization studyand 4 previously untreated animals of the same sexwere used as challenge controls.

The preliminary irritation tests were done in guinea pigs to determine concentrations suitable for sensitization testing [injection challenge concentration(ICC) and application challenge concentration(ACC) ]

The ICC and ACC for the test chemical was determined to be 0.25% and 20% respectively

In the induction phase, 0.1 ml aliquots of test substance at 2.5 times the ICC were injected intradermally at 4 sites which overlie the 2 auxillary and 2 inguinal lymph nodes. After a rest period of 14 days, each animal was challenged intradermally in one flank and topically in the other with 0.1 ml aliquots of test substance at the respective ICC and ACC: the topical application was made by spreading 0.1 ml of the test substance onto the shaved flank in a small circular area which was not covered. Twenty-four hours later the reactions were scored and apparent sensitization reactions confirmed 7 days later by a second challenge with controls included.At each challenge with controls, 4 previously untreated animals of the same sex were treated intradermally and topically on opposite flanks with 0.1 ml aliquots of test substance at the ICC and ACC respectively.  

Individual reactions were considered positive when their total score was significantly greater than the average total score for control reactions. Application reactions were scored on a 0 to +++ scale and individual reactions were considered positive if (a) they were + or greater and (b) there were no erythema reactions in controls.

No signs of contact sensitization were observed at 0. 25% ICC and 20% ACC concentrations. Hence, the test chemical was considered to be non-sensitizing to the skin of albino Hartley guinea pigs. Skin sensitization study was conducted on guinea pigs to observe the sensitization potency of test chemical.

The test chemical could not elicit any sensitization reactions in treated animals. Hence the test chemical can be considered as non-sensitizing to skin of guinea pigs.

 

This is supported by a sensitization study was conducted on guinea pigs to observe the sensitization potency of test chemical.

The test chemical could not elicit any sensitization reactions in treated animals. Hence the test chemical can be considered as non-sensitizing to skin of guinea pigs.

These results are supported by another study performed in guinea pigs to observe the skin sensitization effects of test chemical.

In this study, the test animals were treated dermally with 10% solution of the test chemical during induction. After induction, treated animals were dermally exposed to challenge concentration of 1 or 2% solutions of the test chemical.

Since the test chemical failed to induce any cutaneous reaction at challenge concentrations, the test chemical was considered 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:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical. The studies are as mentioned below:

A Modified Draize Technique was employed to determine the concentrations suitable for sensitization testing [injection challenge concentration(ICC) and application challenge concentration ( ACC) ] of the test chemical. Hartley strain albino guinea pigs bred were used for the study. Four guinea pigs of same sex were used for the preliminary irritation study and 10 guinea pigs were used for the main sensitization study and 4 previously untreated animals of the same sex were used as challenge controls.

The preliminary irritation tests were done in guinea pigs to determine concentrations suitable for sensitization testing [injection challenge concentration(ICC) and application challenge concentration(ACC) ].The ICC and ACC for the test chemical was determined to be 0.25% and 20% respectively In the induction phase, 0.1 ml aliquots of test substance at 2.5 times the ICC were injected intradermally at 4 sites which overlie the 2 auxillary and 2 inguinal lymph nodes. After a rest period of 14 days, each animal was challenged intradermally in one flank and topically in the other with 0.1 ml aliquots of test substance at the respective ICC and ACC: the topical application was made by spreading 0.1 ml of the test substance onto the shaved flank in a small circular area which was not covered. Twenty-four hours later the reactions were scored and apparent sensitization reactions confirmed 7 days later by a second challenge with controls included.At each challenge with controls, 4 previously untreated animals of the same sex were treated intradermally and topically on opposite flanks with 0.1 ml aliquots of test substance at the ICC and ACC respectively.   Individual reactions were considered positive when their total score was significantly greater than the average total score for control reactions. Application reactions were scored on a 0 to +++ scale and individual reactions were considered positive if (a) they were + or greater and (b) there were no erythema reactions in controls. No signs of contact sensitization were observed at 0. 25% ICC and 20% ACC concentrations. Hence, the test chemical was considered to be non-sensitizing to the skin of albino Hartley guinea pigs. Skin sensitization study was conducted on guinea pigs to observe the sensitization potency of test chemical.The test chemical could not elicit any sensitization reactions in treated animals. Hence the test chemical can be considered as non-sensitizing to skin of guinea pigs.

 

This is supported by a sensitization study was conducted on guinea pigs to observe the sensitization potency of test chemical. The test chemical could not elicit any sensitization reactions in treated animals. Hence the test chemical can be considered as non-sensitizing to skin of guinea pigs.

 

These results are further supported by another study performed in guinea pigs to observe the skin sensitization effects of test chemical. In this study, the test animals were treated dermally with 10% solution of the test chemical during induction. After induction, treated animals were dermally exposed to challenge concentration of 1 or 2% solutions of the test chemical. Since the test chemical failed to induce any cutaneous reaction at challenge concentrations, the test chemical was considered as not sensitizing to guinea pigs.

 

Based on the above summarized studies, it can be concluded that the test chemical will also behave in similar manner and will not be able to cause skin sensitization. Hence the test chemical is considered as not sensitizing to the skin. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The skin sensitization potential of test substance and its structurally and functionally similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the test chemical is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.