Registration Dossier
Registration Dossier
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EC number: 950-299-5 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Adequate read-across data are available on alkanes, C14 -17, chloro to predict the properties of di-, tri-, tetrachlorodecane.
No evidence of a skin sensitisation potential was reported in two guinea pig maximisation tests using diluted C14-17 chlorinated paraffins (40 or 45% chlorination, containing 0.2 or 1% epoxy stabiliser).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- End points of target substance di-, tri-, tetra- chlorotetradecane can be read across from source substance Alkanes, C14-17, chloro EC number: 287-477-0 | CAS number: 85535-85-9. This due to the following comparison:
1) di-, tri-, tetra- chlorotetradecane components make up the C14 content found in Alkanes, C14-17, chloro. It is therefore logical that di-, tri-, tetra- chlorotetradecane has been tested as a component of the larger group Alkanes, C14-17, chloro EC number: 287-477-0
2 )The target and read-across molecules are both straight chain and therefore it is considered there are no major difference in steric hindrance between the substances (due to branched chain structures)
3) The functional groups are consistent between the target and read across substances, both are predominantly chlorinated alkanes
To increase the accuracy of the read across, studies used from the Alkanes, C14-17, chloro REACH dossier will only include studies that used C14 components and similar levels of chlorination to di-, tri-, tetra- chlorotetradecane – 35 to 52 % chlorination.
For the above reasons the required endpoint is sufficiently covered by the testing on the read across substance Alkanes, C14-17, chloro EC number: 287-477-0 and the hazard adequately assessed. It is therefore considered that further testing on vertebrates is not required. - Reason / purpose for cross-reference:
- read-across source
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 % in olive oil
- No. with + reactions:
- 0
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20% in olive oil. No with. + reactions: 0.0. Clinical observations: No data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20 % in olive oil
- No. with + reactions:
- 0
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20% in olive oil. No with. + reactions: 0.0. Clinical observations: No data.
- Conclusions:
- No skin sensitisation reactions were seen in a guinea pig maximisation test with the C14-17 chlorinated paraffins, Meflex DC024 or Meflex DC029 (40 or 45% chlorinated, respectively).
Using read across, it can be concluded di-, tri-, tetra- chlorotetradecane would not be classied as skin senstising under CLP. - Executive summary:
No study has been reported for di-, tri-, tetra- chlorotetradecane, but data have been reported for the principal constituents of di-, tri-, tetra- chlorotetradecane that are found in the similar substance Alkanes, C14-17, chloro. However, as Alkanes, C14-17, chloro contains a broad range of chloro-alkanes, only reports using test material containing C14 chloro-alkanes and similar levels of chlorination (35 to 52 % chlorination) have been used for the purposes of read across.
No skin sensitisation reactions were seen in a guinea pig maximisation test with the C14-17 chlorinated paraffins, Meflex DC024 or Meflex DC029 (40 or 45% chlorinated, respectively).
Using read across, it can be concluded di-, tri-, tetra- chlorotetradecane would not be classied as skin senstising under CLP.
- 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:
- End points of target substance di-, tri-, tetra- chlorotetradecane can be read across from source substance Alkanes, C14-17, chloro EC number: 287-477-0 | CAS number: 85535-85-9. This due to the following comparison:
1) di-, tri-, tetra- chlorotetradecane components make up the C14 content found in Alkanes, C14-17, chloro. It is therefore logical that di-, tri-, tetra- chlorotetradecane has been tested as a component of the larger group Alkanes, C14-17, chloro EC number: 287-477-0
2 )The target and read-across molecules are both straight chain and therefore it is considered there are no major difference in steric hindrance between the substances (due to branched chain structures)
3) The functional groups are consistent between the target and read across substances, both are predominantly chlorinated alkanes
To increase the accuracy of the read across, studies used from the Alkanes, C14-17, chloro REACH dossier will only include studies that used C14 components and similar levels of chlorination to di-, tri-, tetra- chlorotetradecane – 35 to 52 % chlorination.
For the above reasons the required endpoint is sufficiently covered by the testing on the read across substance Alkanes, C14-17, chloro EC number: 287-477-0 and the hazard adequately assessed. It is therefore considered that further testing on vertebrates is not required. - Reason / purpose for cross-reference:
- read-across source
- 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).
- Group:
- positive control
- Remarks on result:
- other: no positive control group specified.
- 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). Using read across, it can be concluded di-, tri-, tetra- chlorotetradecane would not be classified as skin sensitising under CLP
- Executive summary:
No study has been reported for di-, tri-, tetra- chlorotetradecane, but data have been reported for the principal constituents of di-, tri-, tetra- chlorotetradecane that are found in the similar substance Alkanes, C14-17, chloro. However, as Alkanes, C14-17, chloro contains a broad range of chloro-alkanes, only reports using test material containing C14 chloro-alkanes and similar levels of chlorination (35 to 52 % chlorination) have been used for the purposes of read across.
No skin sensitisation reactions were seen in a guinea pig maximization test with Chloroparaffin 40G (a C14-17 chlorinated parrafin; 40% chlorinated). Using read across, it can be concluded di-, tri-, tetra- chlorotetradecane would not be classified as skin sensitising under CLP
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No data are available on skin sensitisation potential in humans.
Justification for classification or non-classification
No study has been reported for di-, tri-, tetra- chlorotetradecane, but data have been reported for the principal constituents of di-, tri-, tetra- chlorotetradecane that are found in the similar substance Alkanes, C14-17, chloro. However, as Alkanes, C14-17, chloro contains a broad range of chloro-alkanes, only reports using test material containing C14 chloro-alkanes and similar levels of chlorination (35 to 52 % chlorination) have been used for the purposes of read across.
Based on the available data from two guinea pig maximisation tests using diluted C14-17 chlorinated paraffins (40 or 45% chlorination, containing 0.2 or 1% epoxy stabiliser), di-, tri-, tetrachlorotetradecane would not be classified as a skin sensitiser under EU CLP regulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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