Registration Dossier
Registration Dossier
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EC number: 206-743-9 | CAS number: 372-09-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: robust study summary
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Cyanoacetic acid
- EC Number:
- 206-743-9
- EC Name:
- Cyanoacetic acid
- Cas Number:
- 372-09-8
- Molecular formula:
- C3H3NO2
- IUPAC Name:
- cyanoacetic acid
- Details on test material:
- - Name of test material (as cited in study report): cyanoacetic acid
- Purity test date: 99.3%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall , New church UK
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 317-384g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 1st induction: 30% occlusive epicutanous;
2nd induction: 20% occlusive epicutanous;
3rd induction: 20% occlusive epicutanous;
Challenge: 15% occlusive epicutanous.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 1st induction: 30% occlusive epicutanous;
2nd induction: 20% occlusive epicutanous;
3rd induction: 20% occlusive epicutanous;
Challenge: 15% occlusive epicutanous.
- No. of animals per dose:
- 10 and 10 controls
- Details on study design:
- RANGE FINDING TESTS:
Each of 4 animals received 5, 10, 15, and 20% test substance at 4 different sites, and further 4 animals 30, 50, 70 and 100%. The body weight was determined at day 1 and termination.
30% of the test substance in water caused erythema grade 1 to 2in 2 of 4 animals. 50% caused necrotic patches in 2/4 animals and slight erythema in the 2 other animals. 70% resultesd in necrotic patches in 3/4 animals and moderate erythema in the fourth. 100% induced necrosis in two animals that led to sacrifice of the animals.; the other 2 animals showed moderate erythema. severe necrosis at 3 of 4 sites treated with 70% and 2 of 4 sites treated with 50%. No irritation was seen with 20%.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h occlusive patch
- Site: left shoulder region
- Frequency of applications: day 1, day 8 and day 15,
- Concentrations: day 1 (30%), day 8 and day 15 (20%).
B. CHALLENGE EXPOSURE
- Day(s) of challenge: 2 weeks after final induction,
- Exposure period: 6 h occlusive application,
- Site: shaved right flank,
- Concentrations: 15 %,
- Evaluation (hr after challenge): 24 h, 48 h and 72 h.
- Positive control substance(s):
- yes
- Remarks:
- formaline
Results and discussion
- Positive control results:
- no data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no treatment related clinical signs
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no treatment related clinical signs.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no treatment related clinical signs
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no treatment related clinical signs.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no treatment related clinical signs
- 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: no treatment related clinical signs.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no treatment related clinical signs
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no treatment related clinical signs.
Any other information on results incl. tables
Induction: No dermal reaction in the controls. The first induction with 30% resulted at the 24 h reading in slight or well-defined dermal reaction in 9/10 animals, in 8/10 also necrotic lesions were detected. The application site was therefore relocated for the following inductions and the concentration reduced to 20%. This concentration produced slight to well-defined reactions after the 2nd induction in all treated animals and necrotic patche in 6/10 (comment: in contrast to results of the preliminary study). The 3rd induction resulted in well-defined reactions accompanied by necrotic patches in 10/10 animals.
At challenge 0/10 test animals and 0/10 controls showes a positive skin reaction. Therfore, in this study, cyanoacetic acid did not produce evidence of skin sensitsation (delayed contact hypersensitisation) in any test animal.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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