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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: full report available + GLP

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Guideline:
other: see below
Principles of method if other than guideline:
Klecak et al. Joran, 1982 (contact dermatitis 8:109-116, 1982.)
GLP compliance:
yes
Type of study:
open epicutaneous test

Test material

Constituent 1
Chemical structure
Reference substance name:
Crotonaldehyde
EC Number:
224-030-0
EC Name:
Crotonaldehyde
Cas Number:
4170-30-3
Molecular formula:
C4H6O
IUPAC Name:
but-2-enal
Details on test material:
Received: 1 April 1988
liquid
stored in the freezer at -20C
incompatible with ketones
Sensitive to exposure to air and heat and may also be sensitive to light
readily soluble DMSO, 95% ethanol and acetone.

In vivo test system

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
female
Details on test animals and environmental conditions:
Mice obtained from Taconic Farms. The mice were hepatitis and Sendai virus free. Animals arrived at 4-5 weeks of age (17-21 grams).
1 week quarantine
not used on study until 8 weeks of age
housed 4 animals per cage in plastic shoebox cages with sawdust bedding
Zielger Rat and Mouse Ration (NIH 031)
tap water ad libitum
temperature " 21-24C
relative humidity: 40-60%
12 hour light/dark cycle
cages were cleaned and sanitized twice per week

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Vehicle:
other: 4 parts acetone one part olive oil
Concentration / amount:
10% crotonaldehyde with challenge at 0.3, 1 and 3% crotonaldehyde
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: 4 parts acetone one part olive oil
Concentration / amount:
10% crotonaldehyde with challenge at 0.3, 1 and 3% crotonaldehyde
No. of animals per dose:
8 mice / group
Positive control substance(s):
yes
Remarks:
1-fluoro-2,4-dinitrobenzene (DNFB)

Results and discussion

Positive control results:
hypersensitivity index = 7.5

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
8
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 8.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.3%
No. with + reactions:
0
Total no. in group:
8
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.3%. No with. + reactions: 0.0. Total no. in groups: 8.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1.0%
No. with + reactions:
0
Total no. in group:
8
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 8.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
8
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 8.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
no data
No. with + reactions:
8
Total no. in group:
8
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: positive control. Dose level: no data. No with. + reactions: 8.0. Total no. in groups: 8.0. Clinical observations: no data.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: NA
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: NA

Any other information on results incl. tables

no data

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
negative for skin sensitization potential
Executive summary:

Crotonaldehyde (CRA) was selected for evaluation as a sensitizing agent for contact sensitivity in guinea pigs and mice. The objective of this study was to determine the sensitizing potential of crotonaldehyde when applied dermally to female B6C3F1 mice.

Crotonaldhyde was tested on female B6C3F1 mice. The doses of crotonaldehyde ranged from 0.3% to 3.0% in a solution of 4 parts acetne to one part olive oli (4:1) for sensitization and challenge. Mice received 20 ul by direct dermal application for 5 consecutive days to a prepared site. DNFB (2,4 -dinitrofluorobenzene) (99.6%) was used as a positive control at a concentration of 0.5%. Measurement of the contact sensitivity was accomplihsed byt he radioisotopic assay.

A dose-dependent contact hypersensitivity response to crotonaldehyde could not be demonstrated in mice.

The study was conducted at the Medical College of Virginia Immunotoxicology Laboratory under NTP Contract No. ES 55094.