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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 813-543-0 | CAS number: 73984-93-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jul/Aug 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An existing Buehler study conducted in 1994 on the test substance was available and assessed to have a klimisch score of 1 as it followed OECD protocols and was conducted to GLP standards. Therefore, in the interest of animal welfare it was considered unethical to run the test substance in the LLNA assay
Test material
- Reference substance name:
- 1,3,4-Thiadiazole-2(3H)-thione, 5-(tert-dodecyldithio)-
- EC Number:
- 813-543-0
- Cas Number:
- 73984-93-7
- Molecular formula:
- C14H26N2S4
- IUPAC Name:
- 1,3,4-Thiadiazole-2(3H)-thione, 5-(tert-dodecyldithio)-
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc.
- Weight at study initiation: 413 to 688 g
- Housing: individually housed in wire mesh suspension cages
- Diet: Teklad Guinea Pig Diet ad libitum
- Water: ad libitum
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES:
1994-07-19 - 1994-08-31
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- The test substance was used as supplied.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- The test substance was used as supplied.
- No. of animals per dose:
- 10 males and 10 females for induction and 5 males and 5 females at challenge.
- Details on study design:
- RANGE FINDING TESTS: An irritation screening test was conducted prior to induction.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h once per week for 3 weeks
- Test groups: 10 males and 10 females
- Control group: No
- Site: A clipped area on the back of each animal (site 1) was used for all induction exposures
- Frequency of applications: once per week
- Duration: 6 h once per week for 3 weeks
- Concentrations: test material applied as received i.e. undiluted
B. PRIMARY CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after the last induction exsposure
- Exposure period: 6 h
- Test groups: 10 males and 10 females previously induced
- Control group: 5 males and 5 females naive i.e. not previously induced
- Site: Two clipped areas on the back of each animal (sites 2 and 5) were used for the primary challenge exposure.
- Concentrations: test material applied as received i.e. undiluted
- Evaluation (hr after challenge): 24 and 48 h
C. RECHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1 week after the primary challenge exsposure
- Exposure period: 6 h
- Test groups: 10 males and 10 females previously induced and challenged
- Control group: 5 males and 5 females naive i.e. not previously induced
- Site: Two clipped areas on the back of each animal (sites 4 and 5) were used for the rechallenge exposure
- Concentrations: test material applied as received i.e. undiluted
- Evaluation (hr after challenge): 24 and 48 h - Challenge controls:
- No details available.
- Positive control substance(s):
- yes
- Remarks:
- α-hexylcinnamaldehyde
Results and discussion
- Positive control results:
- Historical positive control data are maintained by Hill Top Labs, the positive control results confirm the reliability of the testing methods used.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 5.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 4.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: naive animals not previously induced. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: naive. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: naive. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: naive. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
The incidence and severity of responses were calculated as follows:
Group |
Incidence of Responses |
Mean Severity Scores |
||||||||||
24h |
48h |
|||||||||||
0 |
± |
1 |
2 |
3 |
0 |
± |
1 |
2 |
3 |
24 h |
48 h |
|
Primary Challenge |
||||||||||||
Test |
3 |
16 |
1 |
0 |
0 |
4 |
14 |
2 |
0 |
0 |
0.5 |
0.5 |
Naïve |
3 |
7 |
0 |
0 |
0 |
3 |
7 |
0 |
0 |
0 |
0.4 |
0.4 |
Rechallenge |
||||||||||||
Test |
0 |
15 |
3 |
2 |
0 |
1 |
15 |
1 |
3 |
0 |
0.7 |
0.7 |
Naive |
0 |
9 |
1 |
0 |
0 |
1 |
9 |
0 |
0 |
0 |
0.6 |
0.5 |
Interpretation
Grades of 1 or greater in an induced group generally indicate sensitisation, provided grades of less than 1 are seen on respective control animals. If grades of 1 or greater are noted on control animals, then the reactions of respective test animals which exceed the most severe control reaction are presumed to be due to sensitisation.
The results of the primary challenge and rechallenge expressed in terms of both incidence and severity of responses and an assessment by comparison of responses in the test groups to those of the corresponding controls;
1. Incidence - the number of animals in each group showing a specific response at either the first or second readings divided by the total number of animals tested in that group (e.g. 10/20);
2. Severity - the sum of the test grades divided by the total number of animals tested in a given group determined separately for both the first and second readings (e.g. 0.8 - 0.7). Grades of ± are equal to 0.5 for the purpose of calculating severity indices. All average grades are to be rounded to the nearest tenth of a unit, unless the severity is between 0 and 0.05, in which case the severity is rounded to the nearest hundredth of a unit.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test report describes a GLP guideline study. The undiluted test substance is considered to be a sensitiser.
- Executive summary:
A skin sensitisation study was conducted using a similar procedure to that described in the current OECD Guideline 406 (Morris, 1994). The test material (CAS No. 50530-43-3) was applied at a volume of 0.3 mL to the backs of 10 male and 10 female Guinea Pigs. The test article was left in contact with the skin for 6 hours. This prodedure was carried out once per week for 3 weeks (induction phase). A primary challenge was then carried out 2 weeks later using the same application procedure as used in the induction phase. This procedure was carried out in the induced animals and in a further group of naive animals. A rechallenge application was then carried out one week after the primary challenge. Scoring was conducted at 24 and 48 h following the primary challenge and the rechallenge phases. The incidence of grade 1 responses in the test group (2 of 20) was compared to that of the naive control group (0 of 10). The incidence and severity of these responses in the test group were greater than those produced by the naive control group indicating that sensitisation to the test material had been induced. The incidence of grade 2 responses in the test group (3 of 20) was compared to that of the naive control group (0 of 10). The incidence and severity of these responses in the test group were again greater than those produced by the naive control group confirming that sensitisation to the test material had been induced.
Under EEC Guidelines, grades of 1 or greater in ≥ 15 % of the test animals results in the classification of the test material as a sensitiser for European labelling purposes. Therefore in accordance with EEC Guidelines, the test material would be labelled as a sensitiser based on the results of the rechallenge exposure.
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.
