Registration Dossier
Registration Dossier
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EC number: 435-080-1 | CAS number: 1070-64-0 6,8-DICHLORETHYLCAPRYLAT; ETHYL-6,8 DICHLORO OCTANOATE
Endpoint summary
Administrative data
Description of key information
In the test substance group, very slight to severe erythema and/or oedema were noted in 16/20 animals at the test substance treated areas 24 hours and/or 48 hours after the end of the challenge exposure. Therefore 16/20 animals (80% of the test substance group animals) were regarded as sensitised.
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
- Study period:
- 3 Sept 1998 to 2 Oct 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performde before LLNA became mandatory
- Specific details on test material used for the study:
- Batch: DS02-01
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Age 6 weeks
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 3%
- Day(s)/duration:
- 0 / 24 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- corn oil
- Remarks:
- 1 + 1 (v/v) with FCA
- Concentration / amount:
- 3 %
- Day(s)/duration:
- 0 / 24 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 %
- Day(s)/duration:
- 7 / 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #20
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Acetone
- Concentration / amount:
- 50 %
- Day(s)/duration:
- 21 / 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animals for test / 10 animals for control
- Positive control substance(s):
- yes
- Remarks:
- Hexyl cinnamic aldehyde
- Positive control results:
- 9/10 annimals with slight to severe erythema and / or oedema
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% in aceton
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% in aceton
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10% in Aceton
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10% in Aceton
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The control sites of all animals of both groups were normal at each reading time.
In the test substance group, very slight to severe erythema and/or oedema were noted in 16/20 animals at the test substance treated areas 24 hours and/or 48 hours after the end of the challenge exposure. Therefore 16/20 animals (80% of the test substance group animals) were regarded as sensitised.
According to the results of this study and to the EC-Guidance 93/21, the test substance 6,8-dichloroethylcaprylate needs to be labelled with "R43 May cause sensitisation by skin contact".
R43 corresponds to H317 accoridng to GHS. - Executive summary:
The control sites of all animals of both groups were normal at each reading time.
In the test substance group, very slight to severe erythema and/or oedema were noted in 16/20 animals at the test substance treated areas 24 hours and/or 48 hours after the end of the challenge exposure. Therefore 16/20 animals (80% of the test substance group animals) were regarded as sensitised.
According to the results of this study and to the EC-Guidance 93/21, the test substance 6,8-dichloroethylcapryate needs to be labelled with "R43 May cause sensitisation by skin contact".
R43 corresponds to H317 accoridng to GHS.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the results of this study and to the EC-Guidance 93/21, the test substance 6,8-dichloroethylcaprylate needs to be labelled with "R43 May cause sensitisation by skin contact".
R43 corresponds to H317 accoridng to GHS.
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