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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Range finding study for 90-day study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Chemical name: Bis(2-chloroethoxy)methane
Batch No.: lot B007269977
Supplier: Karl Industries, Aurora, Ohio,
Purity: 98.5% pure (National Toxicology Program, 2000).

Test animals

Species:
other: rat and mice
Strain:
other: F344 and B6C3F1
Sex:
male/female
Details on test animals and environmental conditions:
TEST SITE
- Area of exposure: back
- % coverage: no data
- Type of wrap if used: no data
- Time intervals for shavings or clipplings: weekly

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The CEM solutions were applied to the shaved skin on the back of rats at 0.5 ml/kg body or to mice at 2.0 ml/kg to deliver doses of 0, 50, 100, 200, 400, or 600 mg/kg body weight.
- Concentration (if solution): Stock solutions, used within a month of preparation and stored in amber glass bottles at room temperature, were formulated at concentrations of 0, 100, 200, 400, 800, and 1,200 mg/ml in 95% ethanol for rats and at 0, 25, 50, 100, 200, or 300 mg/ml in 95% ethanol
for mice.
- Constant volume or concentration used: yes
- For solids, paste formed: not applicable

VEHICLE
- Justification for use and choice of vehicle (if other than water): solubility
- Amount(s) applied (volume or weight with unit): 95%
- Concentration (if solution): 95%
- Lot/batch no. (if required): no data
- Purity: no data

USE OF RESTRAINERS FOR PREVENTING INGESTION: no

Administration / exposure

Type of coverage:
not specified
Vehicle:
ethanol
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
16 (rats) or 17 (mice) days
Frequency of treatment:
5 doses per week
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 12.5, 25, 50, 100, or 200 mg/kg in ethanol (dosing volumes, 0.5 mL/kg for rats and 2 mL/kg for mice)
Basis:
nominal per unit body weight
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
> 400 mg/kg bw/day (nominal)
Sex:
male/female
Basis for effect level:
other: Because of the lack of toxicity in the 2-week study, doses of 0, 50, 100, 200, 400, and 600 mg/kg were selected for the 3-month study in rats and mice.

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Rats and mice

None of the animals died. No effects on body weight or body weight gain, organ wieghts. No clinical findings or histopathological lesions were noted.

Applicant's summary and conclusion

Conclusions:
Because of the lack of toxicity in the 2-week study, doses of 0, 50, 100, 200, 400, and 600 mg/kg were selected for the 3-month study in rats and mice.