Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995-05-29 to 1995-07-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropenyl acetate
EC Number:
203-562-7
EC Name:
Isopropenyl acetate
Cas Number:
108-22-5
Molecular formula:
C5H8O2
IUPAC Name:
isopropenyl acetate
Details on test material:
Name: Isopropenylacetate
Supplied by: Wacker-Chemie GmbH, Johannes-HeB-StraBe 24, D-84489 Burghausen
Chemical name: 1-Propen-2-ol, acetate
Physical state: clear watery liquid
Identification: labelled, where appropriate, with name of test article, batch no., name of sponsor, project no., date of receipt, storage conditions, handling precautions and ex-piry date
Storage: ambient, protected from light
Expiry date : September 3, 1995

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Species:guinea pig
Strain:Pirbright white
Substrain:HsdlWin: DH
Source:Harlan-Winkelmann GmbH, Postfach 11 61, Gartenstr. 27, D-33178 Borchen
Date of receipt:April 12, 1995 (range finding), May 24, 1995 (main test)
Acclimatization period:46 days (range finding), 14 days (main test)
Animal selection: random
Animal identification: with colored markings; cage labelled with sex, date of study initiation, project no.
Weight range (main test): male: 344 - 439 g, female : 346 - 402 g

Housing: collective housing up to a maximum of 5 animals per cage (Makrolon® type IV)
Illumination: artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.
Temperature: 22±3° C
Relative humidity: 30 -70 %
Measurement: twice daily

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
peanut oil
Concentration / amount:
5%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
peanut oil
Concentration / amount:
5%
No. of animals per dose:
10 male/female
Details on study design:
Intradermal Injection: The test article was diluted with aqua ad iniect. and Freund's complete adjuvant to give a final concentration of 5 %. Two animals were employed, skin reactions being recorded 48 h after treatment.
Dermal Application: The test article was used undiluted. A closed patch exposure was effected by means of an occlusive bandage using Hill-Top Chambers and non-irritating tape Elastoplast, which enveloped the whole of the animal's trunk. Two animals were employed and skin reactions were recorded 48 h post applicationem.
Main study: The main study was performed on 20 test and 10 control animals. On the basis of the results of the range finding the concentration of 5 % of the test article was considered to be suitable for intradermal injection and the concentration of 100 % for dermal application
Induction Procedure: First stage - an area of 4 x 6 cm over the shoulders was clipped short with electric clippers and cleaned with 70 % (v/v) ethanol. Three pairs of intradermal injections were then made symmetrically in two rows on either side of the spine:
Test group:
1. 0.1 ml FCA 50 % (w/w) diluted in aqua ad iniect.
2. 0.1 ml test article diluted in peanut oil (final concentration: 5 %)
3. 0.1 ml test article diluted in FCNaqua ad iniect. (final concentration: 5 %)
Control group:
1.0.1 ml FCA 50 % (w/w) diluted in aqua ad iniect.
2. 0.1 ml peanut oil
3.0.1 ml peanut oil 50 % (w/w) diluted in FCA
Second stage - 7 days after the intradermal injections, dermal application was initiated. At the maximum concentration in the pilot study, the test article was non-irritating. Therefore after reclipping, the area was pretreated with 10 % sodium lauryl sulfate (SLS) in vaseline 24 h before application of the test article to induce a mild inflammation. The test article (at a concentration of 100 %) was spread in a thick layer [to saturation] over a 4 x 5 cm patch (filter paper). The latter was firmly secured over the previous injection sites by an occlusive dressing for 48 h. Control animals received a patch loaded with peanut oil.
Challenge procedure: Both control and test animals were subjected to a challenge exposure 14 days after the second stage of induction. The challenge test was performed on a 5 x 5 cm clipped area on each flank of the animals. The maximal non-irritating concentration of the test article (lOO %) was
applied to the left flank and peanut oil to the right in a volume of 0.5 ml using the patch technique described under 4.3.2. In each case the duration of exposure was 24 h under an occlusive dressing. 24 and 48 h after patch removal, the treated skin areas were evaluated on a numerical scale according to Draize.
Challenge controls:
The reaction to the positive control substance 2,4 dinitrochlorobenzene is tested periodically. The last test with acceptable levels of responses to this substance (mild or moderate sensitizer in dependence on the concentration) was performed from December 16, 1994 till January 9, 1995.
Positive control substance(s):
yes
Remarks:
2,4 dinitrochlorobenzene

Results and discussion

Positive control results:
The positive control substance worked as expected.

In vivo (non-LLNA)

Resultsopen allclose all
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:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
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:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.01%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
slight oedema and erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.01%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: slight oedema and erythema.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1%
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
slight oedema and erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: slight oedema and erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.01%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.01%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
slight oedema and erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: slight oedema and erythema.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Isopropenyl acetate did not cause skin sensitizing effects under the conditions of the test performed.
Executive summary:

The skin sensitization potential of Isopropenyl acetate (99.5% pure) was assessed in 10 male and female Pirbright White Hsd/Win:DH guinea pigs using the Magnusson and Kligman maximization test in accordance with OECD Guideline 406. Intradermal induction was accomplished with 5% dilution in peanut oil and with a 5% dilution of the test item in water and Freund’s complete adjuvans. A week after the intradermal induction, the skin was pretreated with 10% sodium lauryl sulphate in petrolatum in order to cause mild irritation 24 hours prior to dermal induction by means of a 48 hour occlusive application of the undiluted test compound. Dermal challenge with undiluted test item through 24 h occlusive application, carried out two weeks after the second induction treatment, elicited no positive skin reactions in any of the guinea pigs treated. Therefore Isopropenyl acetate did not cause skin sensitizing effects under the conditions of this test.