Registration Dossier
Registration Dossier
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EC number: 953-553-3 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Chloroparaffin should not be classified as a skin sensitiser according to EU CLP regulations. Additionally, literaure data suggest the absence of skin sensitization for esters of fatty acids.
Since the target substance is a fatty acid methyl ester and considering that chlorination does not entail an increase of the skin sensitization potential, "Fatty acids, C16-C18(even numbered) methyl esters, chlorinated" should not be considered as a skin sensitizier.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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: According to the draft RAR (EU, 2008), study conducted to current regulatory guidelines
- Qualifier:
- according to guideline
- Guideline:
- other: According to the draft RAR (EU, 2008), study conducted to current regulatory guidelines
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Existing data already available using another assay.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data
- Route:
- other: intradermal and topical
- Vehicle:
- maize oil
- Concentration / amount:
- 20% in maize oil for intradermal induction; undiluted for topical induction. Undiluted for first challenge, 50% in maize oil for second challenge
- Route:
- other: presumably topical
- Vehicle:
- maize oil
- Concentration / amount:
- 20% in maize oil for intradermal induction; undiluted for topical induction. Undiluted for first challenge, 50% in maize oil for second challenge
- No. of animals per dose:
- 20
- Details on study design:
- Skin treated with Freund's Adjuvant prior to topical induction
- Challenge controls:
- 10 (controls); Undiluted for first challenge, 50% in maize oil for second challenge
- Positive control substance(s):
- not specified
- Positive control results:
- No data
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- reaction score of 1; C14-17 chlorinated paraffin (40% chlorination)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: reaction score of 1; C14-17 chlorinated paraffin (40% chlorination).
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- reaction score of 3; C14-17 chlorinated paraffin (40% chlorination)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: undiluted. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: reaction score of 3; C14-17 chlorinated paraffin (40% chlorination).
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin sensitisation reactions were seen in a guinea pig maximization test with Chloroparaffin 40G (a C14-17 chlorinated parrafin; 40% chlorinated)
- Executive summary:
In a guinea pig maximization test, a group of 20 animals were induced with an intradermal injection of 20% Chloroparaffin 40G (a C14-17 chlorinated paraffin; 40% chlorination, containing 1% epoxy stabilizer) in maize oil followed by a topical dose of the undiluted material. The initial challenge was with the undiluted test material and the second challenge with a 50% solution in maize oil. Ten guinea pigs were used as challenge controls.
At topical induction, the undiluted material produced "an intense, sometimes haemorrhagic, purulent inflammation", most likely associated with pre-treatment with Freund's Adjuvant. Following initial challenge, one test and one control animal showed a reaction at 48 h, with a score of 1 and 3, respectively. No skin response was seen after the second challenge.
Under the conditions of this study, Chloroparaffin 40G would not be classified as a skin sensitiser according to EU CLP or DSD regulations.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the data available, the substance should not be classified for skin sensitization under CLP Regulation.
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