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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
on day 1, body weight of all males was higher than 320 g (up to 401 g) and the female No. 6 has kept its dressing only 22 hours instead of 24 hours
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
yes
Remarks:
see above
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
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
Constituent 2
Reference substance name:
4,4-Dithiodimorpholine
IUPAC Name:
4,4-Dithiodimorpholine
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 8 weeks old
- Weight at study initiation: 384 ± 13 g for the males and 248 ± 6 g for the females
- Fasting period before study: none
- Housing: individual polycarbonate cages with stainless steel lid (35.5 cm x 23.5 cm x 19.3 cm). Each cage contained autoclaved sawdust (SICSA, Alfortville, France).
- Diet (e.g. ad libitum): free access to SSNIFF R/M-H pelleted maintenance diet
- Water (e.g. ad libitum): drinking water filtered by a FG Millipore membrane (0.22 micron), provided ad libitum
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 cycles/hour
- Photoperiod (hrs dark / hrs light): 12 h/12 h (7:00 - 19:00)

IN-LIFE DATES: From 11 March 2010 to 25 March 2010

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 cm x 7 cm for the males and 5 cm x 6 cm for the females
- % coverage: 10% of the total body surface of the animals
- Type of wrap if used: gauze pad held in contact with the skin for 24 hours by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test item was removed using a moistened cotton pad.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: yes (substance moistened with 2 mL of purified water)
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
other: historical control data
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed frequently during the hours following administration of the test item, and then at least once a day until day 15. Animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes
Statistics:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None.
Clinical signs:
other: None and no cutaneous reactions.
Gross pathology:
Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions of this study, the dermal LD0 of the test item, 4,4 Dithiodimorpholine, was higher than 2000 mg/kg in rats.
Executive summary:

The acute dermal toxicity of the test item, 4,4 -Dithiodimorpholine, was evaluated in rats according to OECD (No. 402, 24th February 1987) and Commission Regulation (EC) (No. 440/2008, Part B.3, 30 May 2008) guidelines.

The study was conducted in compliance with the principles of Good Laboratory Practice.

 

Methods

The test item, in its original form, was applied for 24 hours to the skin of one group of ten Sprague-Dawley rats (five males and five females) treated at the dose-level of 2000 mg/kg. The test site was covered by a semi-occlusive dressing.

 

Mortality, clinical signs and body weight gain were checked for a period of 14 days following the single application of the test item.

 

On completion of the observation period, the animals were sacrificed then subjected to a macroscopicpost-mortemexamination.

 

Results

No mortality, no clinical signs and no cutaneous reactions were observed during the study.

 

When compared to CIT historical control data, a lower body weight gain was noted in 3/5 males (25 to 33 gvs. 47 ± 7 g in control data base) between day 1 and day 8. The body weight gain of these animals returned to normal thereafter. The body weight gain of the other animals was not affected by the treatment with the test item.

 

No apparent abnormalities were observed at necropsy in any animal.

 

Conclusion

Under the experimental conditions of this study, the dermal LD0of the test item, 4,4 -Dithiodimorpholine, was higher than 2000 mg/kg in rats.