Registration Dossier
Registration Dossier
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EC number: 203-103-0 | CAS number: 103-34-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- n vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparative studies of the sensitization potential of morpholine, 2-mercaptobenzothiazole and 2 of their derivatives in guinea pigs
- Author:
- Wang X and Suskind RR
- Year:
- 1 988
- Bibliographic source:
- Contact Dermatitis, 19, 11-15
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Buehler's method with modifications on duration of exposition (24h, not 6h), number of treated animals (10, not 20)
- GLP compliance:
- not specified
- Type of study:
- other: Buehler's method with modifications
- Justification for non-LLNA method:
- An old study on guinea pigs was performed before REACH regulation. No new study on animals was performed after REACH regulation.
Test material
- Reference substance name:
- Di(morpholin-4-yl) disulphide
- EC Number:
- 203-103-0
- EC Name:
- Di(morpholin-4-yl) disulphide
- Cas Number:
- 103-34-4
- Molecular formula:
- C8H16N2O2S2
- IUPAC Name:
- 4-(morpholin-4-yldisulfanyl)morpholine
- Details on test material:
- no data available
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Brreding Laboratories, Inc. Mass).
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 350-420g
- Housing: in individual cages
- Diet (e.g. ad libitum): a pellet diet
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70 +/- 2°C
- Humidity (%): 45% +/-
- Air changes (per hr): 10 /hr
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- Induction: 5%
Challenge: 0.1, 0.5 and 2%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- Induction: 5%
Challenge: 0.1, 0.5 and 2%
- No. of animals per dose:
- 10 animals/dose
- Details on study design:
- RANGE FINDING TESTS:
-Method = 2 guinea pigs were used to study the skin irritation potential for each compound, preparations of 0.5, 5, 5 and 10% being used to determine the threshold irritation concentration (TIC). 24h before testing, the hair on the flank was shaved. About 0.1 g of each compound was applied to gauze pads (6 layers) of 1.5 cm² dimension. Dermicel was wrapped around the bodies of the animals. Self-adhering foam pads were then applied over the choth tape and secured to the animals' flanks. 24h after application, the test materials were removed. Readings were performed at 1, 24 and 48h after removal of the test substance.
-Result = 5 and 10% concentrations of DTDM produced irritant reactions. The reaction intensity of the 5% preparation, however, was much weaker than of the 10% preparation. The 5% concentration of DTDM resulted in at least a minimal amount of erythema.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 24hr
- Test groups: 0.1g
- Control group: petrolatum
- Site: hair of the nuchal region
- Frequency of applications: 3
- Duration: 2 weeks
- Concentrations: 5% in petrolatum
B. CHALLENGE EXPOSURE
- No. of exposures:
- Day(s) of challenge:
- Exposure period: 24hr
- Test groups: 0.1g
- Control group: pure petrolatum
- Site: left flank of the animals
- Concentrations: 0.1 , 0.5 , 2% in petrolatum
- Evaluation (hr after challenge): 1, 24, 48h and 7 days - Challenge controls:
- no data
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- no data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- 4 with erythema, and 6 with erythema + swelling
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: 4 with erythema, and 6 with erythema + swelling.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- 8 with erythema only
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5% . No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: 8 with erythema only.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- 1 with erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: 1 with erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1, 0.5 and 2%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.1, 0.5 and 2%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: not in the study report
Any other information on results incl. tables
Table : Results of reaction to challenge
Compounds |
No. of animals |
Concentration of challenge and frequency of sensitization |
||||||
2 % |
0.5 % |
0.1 % |
pet |
|||||
+ |
++ |
+ |
++ |
+ |
++ * |
|||
DTDM |
10 |
4 |
6 |
8 |
0 |
1 |
0 |
0 |
Reading made 48h challenge (24h after removal of the compounds tested). * Criteria for grading reactions : + = definite erythema, ++ = erythema and swelling |
||||||||
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- When a 2 % concentration of DTDM was used for the challenge, 100% of the animals reacted to DTDM. With 0.5% concentration, there were 80%.
- Executive summary:
In a modified Buehler's test, group of 10 rats were exposed to 4, 4'-dithiodimorpholine at 5% in petrolatum during the induction period and were challenged with concentrations of 0.1, 0.5 or 2% in petrolatum. Sensitizing reactions were observed in 1, 8 and 10 animals, respectively.
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