[2-(2-methoxymethylethoxy)methylethoxy]propanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study equivalent to OECD guideline 402.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[2-(2-methoxymethylethoxy)methylethoxy]propanol

EC Number:

247-045-4

EC Name:

[2-(2-methoxymethylethoxy)methylethoxy]propanol

Cas Number:

25498-49-1

Molecular formula:

C10H22O4

IUPAC Name:

[2-(2-Methoxymethylethoxy)methylethoxy]propanol

Details on test material:

Propasol Solvent TM
Amount Received: 1 pint
Sample No. 40-130
ID: 511-01-1485
Receipt Date: March 22, 1977

Test animals

Species:

rabbit

Strain:

other: Albino (strain not specified)

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 3 to 5 months old
- Weight at study initiation: weight not specified

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

For a period of 24 hour, TPM was applied under occlusion (impermeable  wrap - polyethylene sheeting) to the clipped, intact skin of the trunk of  male albino rabbits at dose levels of 8.0 or 16 milliliters TPM per kg  body weight.  These dose volumes correspond to 7.72 or 15.4 g/kg (7720 or  15400 mg/kg).  Rabbits were restrained in an undefined manner.  At the  end of the 24-hour application period, excess TPM was removed and the  rabbits were observed for mortality and signs of toxicity for an  unspecified period thereafter (presumably up to 14 days).

Duration of exposure:

24 hour

Doses:

8.0 and 16.0 ml/kgbw. These dose volumes correspond to 7.72 or 15.4 g/kg (7720 or 15400 mg/kg).

No. of animals per sex per dose:

4 per group

Control animals:

not specified

Statistics:

no data

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

15 440 mg/kg bw

Mortality:

16 ml/kg: 2/4
8 ml/kg: 0/4

Clinical signs:

other: The high dose of 16 ml/kg (15400 mg/kg) caused death in 2 of 4 rabbits on  days 2 and 3.  Non-survivors lost 80 and 113 grams of weight and one  subject from this group had an unsteady gait and another was prostrate at  24 hours.  At 8 ml/kg (7720 mg/kg),

Gross pathology:

At necropsy, non-survivors showed mottled livers,  mottled spleens, and full bladders.  Survivors exhibited pale and mottled  kidneys.

Other findings:

None

Any other information on results incl. tables

LD50: 16 ml/kg or 15440 mg/kg

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 of TPM is 16 ml/kg or 15400 mg/kg with a very broad 95% confidence interval ranging from 4.48 to 57.2 ml/kg, according to the authors, of the fractional mortality at the high dose. TPM shows a low order of acute dermal toxicity.

Executive summary:

A sample of Propasol Solvent TM (sample no. 40-130) was evaluated for acute toxicity potential in male albino rabbits. 4 rabbits per group of 3 to 5 months old were used in the study.

For a period of 24 hour, TPM was applied under occlusion (impermeable wrap - polyethylene sheeting) to the clipped, intact skin of the trunk of male albino rabbits at dose levels of 8.0 or 16 milliliters TPM per kg body weight. These dose volumes correspond to 7.72 or 15.4 g/kg (7720 or 15400 mg/kg). Rabbits were restrained in an undefined manner. At the end of the 24-hour application period, excess TPM was removed and the rabbits were observed for mortality and signs of toxicity for an unspecified period thereafter (presumably up to 14 days)

The high dose of 16 ml/kg (15400 mg/kg) caused death in 2 of 4 rabbits on days 2 and 3. Non-survivors lost 80 and 113 grams of weight and one subject from this group had an unsteady gait and another was prostrate at 24 hours. At 8 ml/kg (7720 mg/kg), no rabbits died and no symptoms were reported.

At necropsy, non-survivors showed mottled livers, mottled spleens, and full bladders. Survivors exhibited pale and mottled kidneys.

The dermal LD50 of TPM is 16 ml/kg or 15400 mg/kg with a very broad 95% confidence interval ranging from 4.48 to 57.2 ml/kg, according to the authors, of the fractional mortality at the high dose. TPM shows a low order of acute dermal toxicity.