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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The test was performed in 1997 before the alternative OECD guidelines (LLNA and in vitro test methods) were offically available.

Test material

Constituent 1
Chemical structure
Reference substance name:
1-cyanoallyl acetate
EC Number:
239-743-2
EC Name:
1-cyanoallyl acetate
Cas Number:
15667-63-7
Molecular formula:
C6H7NO2
IUPAC Name:
1-cyanoprop-2-en-1-yl acetate

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: HsdPOC: DH
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen, Germany
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days



Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.5%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.1%
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS:
Determination of the non-irritating concentration in the induction phase

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1
- Site: right flank
- Frequency of applications: days 1, 8, 15
- Duration: 15 days
- Concentrations: 0.5%


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: test day 29
- Exposure period: 6 h
- Test groups: 1
- Control group: 10 animals (no second challenge was performed and 10 control animals were left untreated)
- Site: right flank (test substance) left flank vehicle
- Concentrations: 0.1%
- Evaluation (hr after challenge): 24 and 48 hours


Challenge controls:
Animals of control group
Positive control substance(s):
yes
Remarks:
Proof of sensitivity was done in July/August 1996 with 1,4-phenylenediamine x 2 HCl in Guinea Pigs (ASTA Study No. 913105)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: vehicle 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.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1%
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: 0.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: vehicle 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.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1%
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: 0.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Key result
Reading:
1st reading
Group:
positive control
Dose level:
not given in the report
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Erythema and edema

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Substance has no skin sensitising properties under conditions tested.