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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 940-265-8 | CAS number: -
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-02-24 to 1992-05-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant; Guideline Study (OECD 406)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- April 25, 1984
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- May 12, 1981
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Details on test material:
- - Physical properties: powder;
- Storage conditions: room temperature;
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
- Source: CIBA-GEIGY Limited; Animal Production; 4332 Stein / Switzerland
- Age at study initiation: not stated;
- Weight at study initiation: 346 - 425 g;
- Housing :individually in Macrolon cages (Type 3);
- Diet: standard guinea pig pellets - NAFAG No. 845, Gossau SG, ad libitum;
- Water: fresh water ad libitum;
- Acclimation period: 5 days;
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3°C,
- Humidity: relative humidity of 30 to 70%;
- Air changes (per hr): not stated;
- Light cycle: 12 hours light cycle/day;
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: vaseline (epidermal treatment); physiological saline ( intradermal treatment)
- Concentration / amount:
- Intradermal induction: 5 % in physiological saline;
Epidermal induction: 30 % of the test article in vaseline;
Epidermal challenge: 10 % of the test article in vaseline;
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline (epidermal treatment); physiological saline ( intradermal treatment)
- Concentration / amount:
- Intradermal induction: 5 % in physiological saline;
Epidermal induction: 30 % of the test article in vaseline;
Epidermal challenge: 10 % of the test article in vaseline;
- No. of animals per dose:
- 10 male/10 females in the test group;
5 males/5 females in the control group; - Details on study design:
- RANGE FINDING TESTS:
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of the test item have been examined on separate animals for the determination of the maximum subirritant concentration:
1, 5, 10, and 30% in vaseline.
The tested concentrations did not induce erythema reactions.
Because a higher concentration may lead to nonspecific reactions in adjuvant treated animals, the test article concentration of 10% in vasiline was chosen as subirritant for the challenge application.
MAIN STUDY
A. INDUCTION EXPOSURE
First induction week, intradermal injection:
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows:
- adjuvant/saline mixture 1:1 (v/v)
- test article in physiological saline (w/v)
- test article in the adjuvant saline mixture (w/v)
Second induction week, epidermal application:
In the second week of induction the test item was incorporated in vaseline (w/w) and applied on a filterpaper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g paste per patch; occluded administration for 48 hours).
The application sites were pretreated the day before with 10% sodium lauryl sulfate (open application).
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: during week 5
- Exposure period: 24 hours;
- Test groups: 10 males / 10 females;
- Control group: 5 males / 5 females;
- Site: flank
- Concentrations: 10 % in vaseline
- Evaluation (hr after challenge): 24 h; 48 h;
C. CONTROL GROUP
- A control group of 10 animals (5 m/5 f) was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test article to check the maximum subirritant concentration of the test article in adjuvant treated animals. - Positive control substance(s):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
- Positive control results:
- Results of the latest positive control test (perfomred every six months)
The following concentrations of the reference compound (potassium dichromate) and vehicles were used:
Intradermal induction: Concentration of compound: 0.2%, Vehicle: physiological saline
Epidermal induction: Concentration of compound: 5%, Vehicle: vaseline
Epidermal challenge: Concentration of compound: 1%, Vehicle: vaseline
Number of positive animals per group after occlusive epidermal application:
Control group: after 24 hours: vehicle control: 0/10; test article: 0/10; after 48 hours: vehicle control: 0/10; test article: 0/10;
Test group: after 24 hours: vehicle control: 0/10; test article: 7/10; after 48 hours: vehicle control: 0/10; test article: 6/10;
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 % . No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Under the experimental conditions employed, none of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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.
