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Diss Factsheets

Administrative data

Description of key information

No key or supporting data is available for the registered substance. However, key skin sensitisation data is available from a structurally related substance, C18-C50 branched, cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) and is presented below:

In a Guinea Pig Maximization Test (GPMT), C18-C50 branched, cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) produced a 0% sensitisation rate and was classified as a non-sensitiser to guinea pig skin.

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:
key study
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Positive control results:
Based on the results, under the conditions of the test, the Positive control material, alpha-Hexylcinnamaldehyde, was classified as a sensitiser according to EU labelling regulations Commission Directive 2001/59/EC.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Group:
positive control
Remarks on result:
other: Based on the results, under the conditions of the test, the Positive control material, alpha-Hexylcinnamaldehyde, was classified as a sensitiser according to EU labelling regulations Commission Directive 2001/59/EC

Results
Preliminary Sighting Tests

Skin Reactions Observed After Intradermal Induction

No skin reactions were noted at the intradermal induction sites of the preliminary sighting test animals following treatment with the test material at the concentrations of 100%, 50%, 25%, 12.5%,6.25% and 3.125%.

The concentration chosen for use in the Intradermal Induction phase of the main test was 100% (maximal non necrotising concentration (MNNC)).

Skin Reactions Observed After Topical Induction

No skin reactions were noted at the topical induction sites of the preliminary sighting test animals following treatment with the test material at concentrations of 100%,50%,25% and 12.5%.

The concentration chosen for use in the 2nd topical Induction of the main test was 100% and the

1st concentration chosen for the MNIC (maximal non irritant concentration) determination was 100%.

Skin Reactions Observed After Topical Challenge

No skin reactions were noted at the topical challenge sites of the preliminary sighting test animals following treatment with the test material at concentrations of 100%,50%,25% and 12.5%.

The concentrations chosen for use in the Topical Challenge phase of the main test were 100% (maximal non irritant concentration (MNIC)) and 50% (1/2 MNIC) in liquid paraffin.


Main Study

Skin Reactions Observed After Topical Challenge

100%

No skin reactions were noted at the topical challenge site of the test or control group animals at the 24 and 48 -hour observations.

50% in liquid paraffin

No skin reactions were noted at the topical challenge site of the test or control group animals at the 24 and 48 -hour observations.

Interpretation of results:
other: Not sensitising
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the test material produced a 0% sensitisation rate and was classified as a non-sensitiser to guinea pig skin.
Executive summary:

Introduction.

The study was performed to assess the contact sensitisation potential of the test material ‘Distillates (Fischer-Tropsch), heavy, C18-50 - branched, cyclic and linear’ in the albino guinea pig. The method was designed to meet the requirements of the following:

• OECD Guidelines for the Testing of Chemicals No. 406 "Skin Sensitisation" (adopted 7 July 1992)

• Method B6 Acute Toxicity (Skin Sensitisation) of Commission Directive 96/54/EC

Method.

Ten test and five control animals were used for the main study. Two phases were involved in the main test; an induction of a response by intradelmal injection and topical application and a topical challenge of that response.

Based on the results of sighting tests, the concentrations of test material for the topical induction and topical challenge phases were selected as:

- Intradermal Induction: 100%

- Topical Induction: 100%

- Topical Challenge: 100 % and 50% in liquid paraffin.

Conclusion.

Under the conditions of the test, the test material produced a 0% sensitisation rate and was classified as a non-sensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to Regulation 1272/2008/EC.

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

No key or supporting data is available for Alkanes, C16-47, branched and linear. However, key skin sensitisation data is available from a structurally related substance, C18-C50 branched, cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) and is presented below:

The study was performed to assess the contact sensitisation potential of C18-C50 branched, cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) in the albino guinea pig. The method was designed to meet the requirements of OECD Guideline No. 406 "Skin Sensitisation" and Method B6 Acute Toxicity (Skin sensitisation) of Commission Directive 96/54/EC.

The concentrations of test material for the topical induction and topical challenge phases were selected as:

Intradermal Induction: 100%

Topical Induction: 100%

Topical Challenge: 100% and 50% in liquid paraffin.

Skin Reactions Observed After Topical Challenge

100%

No skin reactions were noted at the topical challenge site of the test or control group animals at the 24 and 48 -hour observations.

50% in liquid paraffin

No skin reactions were noted at the topical challenge site of the test or control group animals at the 24 and 48 -hour observations.

The test material produced a 0% sensitisation rate.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin Sensitisation:

Under the conditions of the test, C18-C50 branched, cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) produced a 0% sensitisation rate and was classified as a non-sensitiser to guinea pig skin.

Based on this key read across data, the registered substance not meet the criteria for classification as a sensitiser according to Regulation 1272/2008/EC.