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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl 6,8-dichlorooctanoate
EC Number:
435-080-1
EC Name:
Ethyl 6,8-dichlorooctanoate
Cas Number:
1070-64-0
Molecular formula:
C10H18Cl2O2
IUPAC Name:
ethyl 6,8-dichlorooctanoate
Test material form:
liquid
Specific details on test material used for the study:
Batch: DS02-01

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
Age 6 weeks

Study design: in vivo (non-LLNA)

Inductionopen allclose all
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
Challenge
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

Results and discussion

Positive control results:
9/10 annimals with slight to severe erythema and / or oedema

In vivo (non-LLNA)

Resultsopen allclose all
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

Applicant's summary and conclusion

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.