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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:
17 April 2002 - 18 May 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
At the time it was justified to carry out a GPMT test for regulatory purposes.

Test material

1
Chemical structure
Reference substance name:
Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate
EC Number:
228-536-2
EC Name:
Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate
Cas Number:
6290-17-1
Molecular formula:
C9H16O4
IUPAC Name:
ethyl 2-(2,4-dimethyl-1,3-dioxolan-2-yl)acetate
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Tierzucht Schonwalde GmbH
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: 348-415 g
- Housing: in polycarbonate cages, with two or three animals per cage
- Diet: free access to a pelleted diet, "Altromin 3122"
- Water: free access to bottles with vitamin C enriched domestic quality water acidified to pH 2.5 with Hydrochloric acid in order to prevent microbial growth.
- Acclimation period: 5 days
- Indication of any skin lesions: no

ENVIRONMENTAL CONDITIONS
- Temperature: 21°C ± 3°C
- Humidity: 55% ± 15%
- Air changes (per hr): 10
- Photoperiod (hours dark/hours light): 12/12
- IN-LIFE DATES: not specified

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
peanut oil
Concentration / amount:
Intradermal: 0.1 mL 2.5 % (v/v)
Epicutaneous: 0.25 mL 100% (v/v)
Day(s)/duration:
20 days
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol/diethylphthalat 1:1
Concentration / amount:
0.1 mL 100% (v/v)
Day(s)/duration:
14 days
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10
Details on study design:
RANGE FINDING TESTS:
- The intradermal irritation of the test article was investigated with two additional animals in order to find the minimal irritant test article concentration for the intradermal induction using intradermal injections as in the main study. Concentrations of 5.0, 2.5, 1.25 and 0.625 %(v/v) were used.
- The topical irritation of the test article was investigated in order to find the minimal irritant test article concentration for the dermal induction, and the maximum nonirritating test article concentration for the challenge application using procedures similar to the main study. Concentrations of 100, 75, 50 and 25 % (v/v) were used.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two: intradermal injections and a closed patch topical application
- Exposure period: 6 days after the injections the topical application was given. Exposure period was 48 hours for the topical application
- Test groups: three pairs of intradermal injections (0.1 mL):
1st pair: Freund's complete adjuvant (FCA) mixed 1:1 with sterile distilled water
2nd pair control group (5 animals): peanut oil
2nd pair test item group (5 animals): test item (2.5% (v/v) in peanut oil)
3rd pair control group (5 animals): equal amounts of peanut oil and FCA/sterile distilled water in the ratio 1:1 (v/v)
3rd pair test item group (5 animals): equal amounts of test item (5% in peanut oil) and FCA/sterile distilled water mixed in the ratio 1:1 (v/v).
- Site: shoulder region

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: 14 days after last induction
- Exposure period: 24 hours
- Test groups: one test group consisting of 10 animals
- Control group: one control group consisting of 5 animals
- Site: flank region
- Concentrations: 100% (v/v)
- Evaluation (hr after challenge): 24 and 48 hours after removal of the patches.
RE-CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: 7 days after the challenge
- Exposure period: 24 hours
- Test groups: one test group consisting of 10 animals
- Control group: one control group consisting of 5 animals
- Site: right flank region
- Concentrations: 75% (v/v)
- Evaluation (hr after challenge): 24 and 48 hours after removal of the patches.
Challenge controls:
A control group of 5 animals was included in the challenge phase.
To confirm the resuits of the challenge a rechallenge in the right flank region was performed one week after the challenge in the same manner, but with a test article concentration of 75 % (v/v).
Positive control substance(s):
yes
Remarks:
α-hexylcinnamaldehyde (23 October 2001-16 November 2001)

Results and discussion

Positive control results:
80 % of the animals responded positively in the positive control study

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100% (v/v)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No abnormalities were observed and bodyweight gain was normal.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100% (v/v)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No abnormalities were observed and bodyweight gain was normal.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100% (v/v)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No abnormalities were observed and bodyweight gain was normal.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100% (v/v)
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
No abnormalities were observed and bodyweight gain was normal.
Remarks on result:
other: slight erythema was observed in 2/10 animals
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
75% (v/v)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No abnormalities were observed and bodyweight gain was normal.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
75% (v/v)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No abnormalities were observed and bodyweight gain was normal.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
75% (v/v)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No abnormalities were observed and bodyweight gain was normal.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
75% (v/v)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No abnormalities were observed and bodyweight gain was normal.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
85%
Remarks on result:
other: see Remark
Remarks:
Hexyl cinnamic aldehyde was used as a positive control (16th November 2001). The intradermal induction was 10% and topically 100%. The percentage animals reacting positive was 80%

Applicant's summary and conclusion

Interpretation of results:
other: Not a skin sensitizer
Remarks:
In accordance with EU CLP (EC No. 1272/2008 and its amendments)
Conclusions:
Based on the results of a skin sensitisation study with guinea pigs (GPMT), performed according to OECD 406 guideline and under GLP, the substance is considered not to be a skin sensitizer.
Executive summary:

A guinea pig maximisation test was performed, according to OECD 406 guideline and GLP, to assess the skin sensitising potential of the substance. 15 female guinea pigs, 10 for the test group and 5 for the control group, were used. The study consisted of an induction phase, a challenge phase and a rechallenge phase. In the induction phase (20 days) intradermal injections as well as topical application in the shoulder region were given. For the intradermal injections, a concentration of 2.5 % (v/v) of the substance was used, whereas in the topical application a concentration of 100% (v/v) was used. The irritation in the preliminary test was not presented. In view of the maximum 100% used for topical induction this is considered acceptable. In the challenge phase the substance was only applied occlusively on the skin in the flank region at a concentration of 100% (v/v). Results of the challenge phase showed slight erythema in 2 out of 10 animals in the test group. One week after the challenge phase, a rechallenge phase was carried out in the right flank using a concentration of 75% (v/v) of the substance. No effects were seen in the rechallenge phase. No clinical abnormalities were observed and bodyweight gain was normal during the study.