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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

 Adequate read-across data are available on alkanes, C14 -17, chloro to predict the properties of   di-, tri- and tetrachlorotetradecane.

No deaths or other severe adverse affects were reported in a number of acute oral studies, in which rats were given single doses of C14-17 chlorinated paraffins (40 -52% chlorination; with or without 0.2-1% epoxy stabiliser).  The oral LD50 is greater than 10 mL/kg bw. There are no acute inhalation or dermal exposure studies on  di-, tri- and tetrachlorotetradecane available in laboratory animals. No acute human data is available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
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
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Remarks on result:
other: No confidence intervals given
Mortality:
No deaths observed
Clinical signs:
other: Clinical signs of toxicity were not mentioned in respect of the C14-17 chlorinated paraffins, being confined "mainly" to rats which received a high dose (4 g/kg bw or above) of the C10-13 chlorinated paraffins. They included piloerection, muscular incoord
Gross pathology:
The general comment was that hepatocellular vacuolation and occassional necrotic foci were seen in the liver and cloudy swelling of some inner cortical cells was seen in the kidney. These effects were mainly seen in the animals treated with the C10-13 chlorinated parafins, which showed signs of toxicity, and were not mentioned specifically for the C14-17 chlorinated paraffin-treated rats.
Other findings:
- Other observations: occasional inflamation of the gastric mucosa was observed following administration of "some chlorinated paraffins" (not further specified in review).

No data is presented on which specific chlorinated paraffin the effects were attributed, the dose levels at which the effects occurred, or on whether the test material contains added stabilizer (0.2% epoxidized vegetable oil). It is not possible to delineate the results of the work on SCCPs and MCCPs

Interpretation of results:
GHS criteria not met
Conclusions:
No deaths or other severe adverse effects were seen in rats given single unspecified doses of various C14-17 chlorinated paraffins (ranging from 51-60% chlorination) by stomach tube (from between 0.5 and 10 g/kg bw) and observed for 14 days. The acute oral LD50 was reported as greater than 4 g/kg bw.
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 deaths or other severe adverse effects were seen in rats given single unspecified doses of various C14-17 chlorinated paraffins (ranging from 51-60% chlorination) by stomach tube (from between 0.5 and 10 g/kg bw) and observed for 14 days.  The acute oral LD50 was reported as greater than 4 g/kg bw.

Endpoint:
acute toxicity: oral
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
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Based on:
test mat.
Remarks on result:
other: No confidence limits given
Mortality:
No deaths reported.
Clinical signs:
other: Restricted to incontinence during the first 48 hours, although numbers of animals affected and with which specific test material not reported.
Gross pathology:
No data
Other findings:
No data

No data was available on the effects of the individual materials on individual animals

Interpretation of results:
GHS criteria not met
Conclusions:
No deaths or other severe adverse effects were seen in rats observed for 14 days following gavage administration of Meflex DC024 or Meflex DC029 (C14-17 chlorinated paraffins; 40 or 45% chlorination) as a single oral dose at 10 ml/kg bw . The oral LD50 is greater than 10 ml/kg bw.
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.

The oral LD50 is greater than 10 ml/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The acute oral LD50 for di-, tri- and tetrachlorotetradecane in rats is greater than 2 g/kg bw. According to EU CLP regulation, under the conditions of these studies, di-, tri- and tetrachlorotetradecane would not be classified as acutely toxic by the oral route.