Bis(2-chloroethoxy)methane 1,15-dichloro-3,5,8,11,13-penta-oxa pentadecane1-(2-chloroethoxy)-2-(2-chloroethoxymethoxy)ethane

Repeated dose toxicity: dermal

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

Test material information

Constituent 1

Reference substance name:

Bis(2-chloroethoxy)methane

EC Number:

203-920-2

EC Name:

Bis(2-chloroethoxy)methane

Cas Number:

111-91-1

Molecular formula:

C5H10Cl2O2

IUPAC Name:

1-chloro-2-((2chloroethoxy)methoxy)ethane

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 or test system 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.