Butanamide, N-(3-ethoxypropyl)-2,4-dihydroxy-3,3-dimethyl-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 1994-08-11 to 1994-08-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study followed the procedures indicated by internationally accepted guidelines and recommendations as Commission Regulation (EC) No 440/2008 (B.3: Acute Toxicity (Dermal)).

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

directive 92/69/EEC

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation:approx. 8 weeks
- Weight at study initiation: males: mean 207 g; females: mean 175 g
- Fasting period before study: no
- Housing: polycarbonate cages, 5 animals per sex per cage
- Diet: standard pelleted laboratory animal diet (Kliba 343 from Klingentalmuhle AG, Kaiseraugst, Switzerland) ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 50 % rel. humidity
- Air changes: approximately 15 air changes per hour
- Photoperiod: 12 hours artificial fluorescent light and 12 hours dark per day.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: approx. 25 cm² (5 x 5 cm) for males and 18 cm² (3.5 x 5 cm) for females
- Type of wrap if used: aluminium foil and flexible bandage (Coban, 3M, St. Paul, U.S.A.)

REMOVAL OF TEST SUBSTANCE
- Washing: residual test substance was removed using a tissue moistened with tap water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg (1.869 mL/kg) body weight. Dose volume calculated as follows: dose level : specific gravity

Duration of exposure:

24 hours

Doses:

single dose: 2000 mg/kg b.w.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality/viability: twice daily; body weights on day 1, 8, and 15;
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs: at periodic intervals on the day of the treatmen (day 1) and once daily thereafter, until day 15. The time of onset, degree and duration were recorded.

Results and discussion

Preliminary study:

NA

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of ill health or behavioural changes were observed during the study period. Abnormalites in the treated skin area included scabs in one male between days 5 and 9.

Other findings:

Macroscopic post mortem examination of the animals at termination revealed a yellowish hard nodule in the papillary process of the liver in one female and pelvic dilation of the kidney in one male. These findings are incidentally noted among the animals of this age and strain and are considered not related to treatment with the test substance.

Any other information on results incl. tables

no remarks

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 value of the test item in rats was established as exceeding 2000 mg/kg body weight.

Executive summary:

In an acute dermal toxicity study, groups of young adult (8 weeks old) Wistar rats (5/sex) were dermally exposed to the test item for 24 hours to (25 cm2 surface) at a limit doses 2000 mg/kg bw. Animals then were observed for 14 days.

No mortality occurred during the study period. No clinical signs of ill health or behavioural changes were observed during the study period. Abnormalites in the treated skin area included scabs in one male between days 5 and 9. The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain. However, three females showed low body weight gain over the second week of the study. Macroscopic post mortem examination of the animals at termination revealed a yellowish hard nodule in the papillary process of the liver in one female and pelvic dilation of the kidney in one male. These findings are incidentally noted among the animals of this age and strain and are considered not related to treatment with the test substance. The dermal LD50 value of the test item in rats was established as exceeding 2000 mg/kg body weight.