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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
: lack of details on test substance
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test was done before LLNA as first-choice method for in-vivo testing was set into force.
Species:
guinea pig
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Group:
positive control
Remarks on result:
other: no data available
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is one study regarding skin sensitisation with C12-14AS TEA (CAS 90583-18-9) available.

The skin sensitizing potential of C12-14AS TEA (CAS 90583-18-9, analytical purity 41-42%) was assessed in a Guinea Pig Maximisation Test similar to OECD Guideline 406 (Potokar, 1977). In this study 20 guinea pigs were induced by intradermal application of the test item at concentrations of 5% (based on active ingredient) in presence or absence of Freundsches adjuvant. A second induction was performed one week thereafter via epicutaneous application of the test item at concentrations of 5%. Challenge was performed with 1% (based on active ingredient) after 14 days. All animals were scored for skin reactions 24, 48 and 72 h after challenge. Irritating effects were seen after intradermal application of the test substance in presence or absence of Freundsches Adjuvant. These effects reversed until the challenge experiment. No skin reactions were observed upon challenge.

Results of the study show that C12-14AS TEA (CAS 90583-18-9) is not a skin sensitiser. In addition, sodium lauryl sulphate (C12AS Na) was recommended within this study as known irritant to produce irritant effects. Likewise sodium lauryl sulphate is also recommended as an agent to induce local irritation in an OECD method to assess skin sensitising properties of chemicals (OECD Guideline 406, Guinea Pig Maximisation Test). Therefore, there is a lot of experience with sodium lauryl sulfate in sensitising studies and no evidence that it shows sensitising properties. Thus, skin sensitisation by members of the alkyl sulfates category is generally unlikely.


Migrated from Short description of key information:
Skin sensitisation (GPMT - OECD 406): not sensitising

Justification for selection of skin sensitisation endpoint:
Reliable study performed smilat to OECD guideline.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

No data available for respiratory sensitisation.