Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from handbook.

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Acute dermal toxicity study of test chemical in rodents.
Author:
Richard J. Lewis
Year:
2012
Bibliographic source:
Sax's Dangerous Properties of Industrial Materials
Reference Type:
review article or handbook
Title:
Acute Toxicity - TEST SUBSTANCE
Author:
John Wiley & Sons
Year:
2005
Bibliographic source:
Patty's Industrial Hygiene and Toxicology
Reference Type:
other: authoritative database
Title:
Acute Dermal toxicity - Test chemical
Author:
U.S. National Library of Medicine
Year:
2018
Bibliographic source:
ChemIDplus
Reference Type:
other: Authoritative database
Title:
Toxicity of test chemical
Author:
IFA GESTIS
Year:
2018
Bibliographic source:
GESTIS Substance Database
Reference Type:
secondary source
Title:
Acute dermal toxicity study of test chemical in rabbits
Author:
NTRL
Year:
1991
Bibliographic source:
NTRL report

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
The toxicity study was examined to evaluate the acute toxic effects of administration of the test chemical in male New Zealand White rabbits by the dermal route.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- IUPAC Name: Dimethyl sulphone
- InChI: 1S/C2H6O2S/c1-5(2,3)4/h1-2H3
- Smiles: S(C)(C)(=O)=O
- Molecular formula :C2H6O2S
- Molecular weight :94.1334 g/mole
- Substance type:Organic
- Physical state:Solid, crystalline white odorless

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Skippack Farms
- Weight at study initiation: mean wt: 2.23

Administration / exposure

Type of coverage:
occlusive
Vehicle:
physiological saline
Details on dermal exposure:
TEST SITE
- Area of exposure: The closely clipped skin.
- Type of wrap if used: The test chemical was held under an impervious cuff.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The cuffs were removed and the application sites were gently wiped to remove the test substance.
- Time after start of exposure:24-hr

TEST MATERIAL
- For solids, paste formed: yes, the test substance, prepared as a paste in saline (1:1)
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
Total = 2
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: Animals were observed for mortality and clinical signs.
- Necropsy of survivors performed: yes
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed at the dose concentration of 5000 mg/kg bw.
Clinical signs:
Well defined erythema and very slight edema was observed.
Body weight:
not specified
Gross pathology:
No gross changes were observed in either rabbit.
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The acute dermal LD50 value was considered to be >5000 mg/kg bw, when 2 male New Zealand White rabbits were treated with the given test chemical by dermal application occlusively.
Executive summary:

The acute dermal toxicity study was conducted by using the given test chemical in 2 male New Zealand White rabbits at the dose concentration of 5000 mg/kg bw.

The test substance, prepared as a paste in saline (1:1), was held under an impervious cuff in continuous 24 hr contact with the closely clipped skin. After the 24-hr exposure, the cuffs were removed and the application sites were gently wiped to remove the test substance. Animals were observed for mortality and clinical signs. Necropsy of survivors performed.

No mortality was observed at the dose concentration of 5000 mg/kg bw. Well defined erythema and very slight edema was observed. No gross changes were observed in either rabbit.

Hence, the LD50 value was considered to be >5000 mg/kg bw, when 2 male New Zealand White rabbits were treated with the given test chemical by dermal application occlusively.