Registration Dossier
Registration Dossier
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EC number: 700-526-7 | CAS number: 1333488-95-1
Skin sensitisation
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: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- methyl (2E)-2-cyano-3-(2,2-difluoro-1,3-benzodioxol-4-yl)prop-2-enoate
- EC Number:
- 700-526-7
- Cas Number:
- 1333488-95-1
- Molecular formula:
- C12H7F2NO4
- IUPAC Name:
- methyl (2E)-2-cyano-3-(2,2-difluoro-1,3-benzodioxol-4-yl)prop-2-enoate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 306 - 449 g
- Housing: individually in Macrolon cages type 3
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
- Sensitivity of the strain: checked every six months with known sensitizers
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1991-02-18 To: 1991-03-21
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Remarks:
- Vaseline
- Concentration / amount:
- First induction week (intradermal injection): 3% in Ol. arachidis
Second induction week (epidermal application): 30% in vaseline
Challenge (epidermal application): 10% in vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Remarks:
- Vaseline
- Concentration / amount:
- First induction week (intradermal injection): 3% in Ol. arachidis
Second induction week (epidermal application): 30% in vaseline
Challenge (epidermal application): 10% in vaseline
- No. of animals per dose:
- 20 (10 males, 10 females)
- Details on study design:
- First induction week (intradermal injection):
3 pairs of intradermal injections (0.1 mL):
- adjuvant/saline mixture 1:1 (v/v)
- test material in Ol. arachidis (w/v)
- test material in the adjuvant saline mixture (w/v)
Second induction week (epidermal application):
Test material incorporated in vaseline (w/w), patch applied to the neck of the animals (patch 2x4 cm, 0.4 g paste, occluded for 48 h)
The application sites were pretreated the day before with 10% sodium lauryl sulfate (open application).
Challenge (epidermal application, week 5):
Animals were tested tested on the flank with the test material in vaseline (w/w) and the vehicle alone (patch 2x2 cm, 0.2 g paste, occluded for 24 h)
Grading:
24 h after removal of the dressings, the challenge reactions were graded according to the Draize scoring scale. A second evaluation was made 48 h after removal of the dressings. - Challenge controls:
- A control group of 10 animals (5 males, 5 females) was treated with adjuvant and the vehicle during the induction period. For challenge the group was treated with the vehicle as well as the test material to check the maximum subirritant concentration of the material in adjuvant treated animals.
- Positive control substance(s):
- no
- Remarks:
- Not included in this test. However, strain sensitivity is checked every six months with known sensitizers.
Results and discussion
- Positive control results:
- Reference values with Potassium dichromate (in life phase: 03-09-1990 to 04-10-1990):
Positive results in 6/20 animals after 24 h and 7/20 animals after 48 h.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- Erythema score up to 2, edema score up to 2
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30%. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: Erythema score up to 2, edema score up to 2.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- Erythema score up to 2, edema score up to 1
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: Erythema score up to 2, edema score up to 1.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control vehicle
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control vehicle. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control vehicle
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control vehicle. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control test material
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control test material. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control test material
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control test material. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
20 to 25% of the animals were sensitized by CGA 224740 tech. under the experimental condictions employed. CGA 224740 tech. is therefore classified as a mild sensitizer in albino guinea pigs according to the grading of Magnusson and Kligman.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information according to EU GHS
- Conclusions:
- Under the conditions of this skin sensitization study in the guinea pig the test item was not sensitizing.
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