di-, tri- and tetrachlorotetradecane

Endpoint summary

Description of key information

 Adequate read-across data are available on alkanes, C14 -17, chloro to predict the properties of   di-, tri- and tetrachlorotetradecane. In OECD guideline studies, slight skin and slight eye irritation were reported in rabbits exposed to undiluted C14-17 chlorinated paraffins (40 and 52% chlorination, containing 1% epoxy stabiliser). Slight skin irritation was also reported in additional unpublished studies in rabbits and rats. There are no data specifically in relation to upper respiratory tract irritation but on the basis of the low skin and eye irritation potential and generally unreactive nature, and the lack of human reports, it is anticipated that  di-, tri- and tetrachlorotetradecane are unlikely to cause such an effect.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

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

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.5

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: C14-17 chlorinated paraffin (40% chlorinated)

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.6

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: C14-17 chlorinated paraffin (40% chlorinated)

Irritant / corrosive response data:

no data

Other effects:

Scales were seen on the 6th to 10th days after exposure, preceded by drying and hardness of the skin at 72 hours. Peeling was observed on days 6 to 8.

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Conclusions:

No corrosion was seen to the skin of rabbits treated with a single (4 h) application of Chloroparaffin 40G (a C14-17 chlorinated paraffin; 40% chlorination, containing 1% epoxy stabiliser) under occlusive conditions. Only mild irritation was seen, characterised by slight erythema and slight oedema at 24-72 h, drying and hardness at 72 h, peeling of presumably the outermost layers of the skin on days 6 to 8 and the presence of scales on days 6 to 10 after application. Using read across, it can be concluded di-, tri-, tetra- chlorotetradecane would cause mild irritation.

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 corrosion was seen to the skin of rabbits treated with a single (4 h) application of Chloroparaffin 40G (a C14-17 chlorinated paraffin; 40% chlorination, containing 1% epoxy stabiliser) under occlusive conditions. Only mild irritation was seen, characterised by slight erythema and slight oedema at 24-72 h, drying and hardness at 72 h, peeling of presumably the outermost layers of the skin on days 6 to 8 and the presence of scales on days 6 to 10 after application. Using read across, it can be concluded di-, tri-, tetra- chlorotetradecane would cause mild irritation.

Reference 2

Endpoint:

skin irritation: in vivo

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

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: C14-17 chlorinated paraffin (52% chlorinated)

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: C14-17 chlorinated paraffin (52% chlorinated)

Irritant / corrosive response data:

no data

Other effects:

Scales were seen on the 6th to 10th days after exposure.

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Conclusions:

No corrosion was seen to the skin of rabbits treated with a single dermal application (4 h) of Chloroparaffin 52G (a C14-17 chlorinated paraffin; 52% chlorination, containing 1% epoxy stabiliser) under occlusive conditions. Only mild irritation was seen, characterised by slight erythema and slight oedema, at 24-72 h. Scales were seen on the treated skin between 6 and 10 days after application. Using read across, it can be concluded di-, tri-, tetra- chlorotetradecane would cause mild irritation.

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 corrosion was seen to the skin of rabbits treated with a single dermal application (4 h) of Chloroparaffin 52G (a C14-17 chlorinated paraffin; 52% chlorination, containing 1% epoxy stabiliser) under occlusive conditions. Only mild irritation was seen, characterised by slight erythema and slight oedema, at 24-72 h. Scales were seen on the treated skin between 6 and 10 days after application. Using read across, it can be concluded di-, tri-, tetra- chlorotetradecane would cause mild irritation.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

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

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 1-2 hr

Score:

3.3

Max. score:

110

Reversibility:

not specified

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 7 days

Score:

0

Max. score:

80

Reversibility:

not specified

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 7 days

Score:

0

Max. score:

80

Reversibility:

not specified

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1-2 hr

Score:

3.3

Max. score:

20

Reversibility:

not specified

Irritant / corrosive response data:

Both materials caused slight, transient conjuctivitis (score 3 on 1-8 scale)

Other effects:

Pain score at instillation - 2 (scale 0-5)

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the test items C14-17 chlorinated paraffin; 40% chlorination & C14-17 chlorinated paraffin; 45% chlorination were judged to be slight eye irritants. Therefore di-, tri-, tetra- chlorotetradecane would not be classified as capable of producing serious eye damage/eye irritation under the EU CLP regulations.

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.

Under the conditions of this study, the test items C14-17 chlorinated paraffin; 40% chlorination & C14-17 chlorinated paraffin; 45% chlorination were judged to be slight eye irritants. Therefore di-, tri-, tetra- chlorotetradecane would not be classified as capable of producing serious eye damage/eye irritation under the EU CLP regulations.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

No data are available in humans relating to skin or eye irritation, and no data in relation to respiratory irritation in humans or animals.

 

Only slight skin irritation (mean 24-72 h scores for erythema and oedema were 1.5 and 0.6, and 1.3 and 0.3, respectively) was reported in two studies (Kuhnert, 1986c,d) conducted according to OECD Guideline 404, in which rabbits were exposed for 4 h (occluded) to undiluted C14-17 chlorinated paraffins (40 and 52% chlorination respectively, containing 1% epoxy stabiliser). Scales were also seen from the 6th to 10th day following exposure, and in the case of the first study, drying and hardness (at 72 h) and “peeling” (observed on days 6-8) presumably of the outermost layers of the skin was seen. In briefly reported unpublished studies in rabbits and rats (Birtley et al. 1980; Chater, 1978; Moses, 1980), desquamation and/or slight irritation were noted after single and/or repeated skin application of C14-17 chlorinated paraffins (40-60% chlorination, containing 0.2% stabiliser). Overall, all of these studies, although having some limitations in reporting, are consistent and indicate that MCCPs have only slight skin irritation potential. In one of the studies (Chater, 1978), a poorly reported study which does not meet current guidelines, some cracking of the skin was seen (probably because of defatting) in two out of three rats following six skin applications (over 12 days) of undiluted Meflex DC024 or DC029 (C14-17 chlorinated paraffins; 40 and 45% chlorinated, respectively). However, skin cracking was not reported in a number of other in vivo skin irritation studies involving repeated dermal application of C14 -17 chlorinated paraffins (Birtley et al. 1980; Moses, 1980).

 

Two guideline studies (OECD 405) indicate that undiluted C14-17 chlorinated paraffins (40 and 52% chlorination respectively, containing 1% epoxy stabiliser) produce only slight eye irritation when instilled into the conjunctival sac of each of 3 rabbits (Kuhnert, 1986e,f). "Slight transient conjunctivitis" was seen shortly after C14-17 chlorinated paraffins (40 and 45% chlorination, containing 0.2% epoxy stabiliser) were instilled into the conjunctival sac of each of 3 rabbits (Chater, 1978). No irritation was noted in briefly reported unpublished studies (Birtley et al. 1980), involving a single application of different types of C14 -17 chlorinated paraffins (51-60% chlorination) into the eyes of rabbits.

 

There are no data specifically in relation to respiratory tract irritation. However, the lack of any reports relating to this endpoint given the widespread use of these substances, suggests that they lack the potential to cause such an effect. The low skin and eye irritation potential and generally unreactive nature of this group of substances lends further support to this view.

Although there is only limited information the degree of chlorination does not appear to be of significance for these endpoints.

Justification for classification or non-classification

No study has been reported for di-, tri- and tetrachlorotetradecane, but data have been reported for the principal constituents of di-, tri- and tetrachlorotetradecane 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 slight, reversible, skin irritation seen in rats and rabbits, and the slight eye irritation seen in rabbits exposed to the undiluted material, di-, tri-, tetrachlorotetradecane would not be classified as skin or eye irritants according to the EU CLP regulations. In a poorly reported study (which does not meet current standards), some potential for cracking of the skin was noted following repeated dermal application of an undiluted liquid MCCP to rats, probably via a defatting mechanism. However, such an effect was not seen in a number of other repeated dermal studies with undiluted MCCPs in rats, and no reports of skin cracking in humans has been reported.

Therefore, di-, tri- and tetrachlorotetradecane would not be classified as 'repeated exposure may cause skin dryness or cracking’