Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 401-540-3 | CAS number: 84632-65-5
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: Guideline study conducted according to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Details on test material:
- - Physical state: solid
- Purity: commercial grade
- Stability under test conditions: In the report it was stated that stability was guaranteed by the sponsor.
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, Sisseln, Switzerland
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 304 - 461 g
- Housing: individually in Macrolon type-3 cages.
- Diet (ad libitum): standard guinea pig pellets, NAFAG No. 846
- Water (ad libitum): fresh water
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: For intradermal treatment sesame oil and for epidermal treatment vaseline was used as vehicle.
- Concentration / amount:
- Intradermal induction was performed with 1 % dilution of test article in sesame oil or in adjuvant/physiological saline. A 1:1 mixture of adjuvant and saline served as control.
Epidermal induction was conducted with 10 % test article in vaseline as a paste of 0.4 g.
The challenge was performed with 0.3 % test article in vaseline as paste of 0.2 g.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: For intradermal treatment sesame oil and for epidermal treatment vaseline was used as vehicle.
- Concentration / amount:
- Intradermal induction was performed with 1 % dilution of test article in sesame oil or in adjuvant/physiological saline. A 1:1 mixture of adjuvant and saline served as control.
Epidermal induction was conducted with 10 % test article in vaseline as a paste of 0.4 g.
The challenge was performed with 0.3 % test article in vaseline as paste of 0.2 g.
- No. of animals per dose:
- 20 animals (10 males, 10 females)
- Details on study design:
- RANGE FINDING TESTS
The concentration of the test compound for the induction and challenge periods were determined on four separate animals with concentrations of 0.3 %, 1 %, 3 %, 10 %. No further details are given.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2; one intradermal injection (0.1 ml/site) of 1 % dilution in sesame oil and one epidermal application of 10 % dilution in vaseline one week after intradermal injection under occlusive conditions.
- Exposure period: Epidermal application was performed for 48 h.
- Site: neck
B. CHALLENGE EXPOSURE (TWO WEEKS AFTER INDUCTION)
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 h
- Site: flank
- Concentrations: 0.3 % test article in vaseline
- Evaluation (hr after challenge): approximately 24 and 48 hours after challenge
SCORING
Evaluation of skin reactions according to Draize (1959)
Erythema and eschar formation
- No erythema 0
- Very slight erythema (barely perceptible) 1
- Well defined erythema 2
- Moderate to severe erythema 3
- Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema formation
- No edema 0
- Very slight edema (barely perceptible) 1
- Slight edema (edges of area well defined by definite raising) 2
- Moderate edema (raised approximately 1 mm) 3
- Severe edema (raised more than 1 mm and extending beyond area of exposure) 4 - Challenge controls:
- During the induction period a control group was treated with adjuvant and the vehicle. One half of this group was challenged with vehicle and the other half with test article.
- Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the strain is checked every six months with paraphenylene-diamine or potassium-dichromate according to Maurer and Hess 1994 (Toxicology 31, 217-222) in the testing facility.
Results and discussion
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:
- 20
- Clinical observations:
- no skin irritations were observed
- 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: 20.0. Clinical observations: no skin irritations were observed .
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin irritations were observed
- 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: 20.0. Clinical observations: no skin irritations were observed.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.3 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin irritations were observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.3 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no skin irritations were observed .
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin irritations were observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.3 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no skin irritations were observed .
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
