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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported. Test material was received 12 July 1977, study report was finalised 7 December 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Two male and 2 female New Zealand White rabbits (obtained from Kuiper's Rabbit Ranch, Gary, Indiana) were used for this study. The rabbits weighed from 2308 to 2370 grams at the beginning of this study. They were individually housed in metal metabolism cages in temperature and humidity controlled quarters. They were maintained in accordance with the recommendations contained in H.E.W. Publication No. 74-23 (N.I.H.) entitled "Guide for the Care and Use of Laboratory Animals". Water and Purina Rabbit Chow were available ad libitum. Body weights were measured initially and at 7 and 14 days.

The hair was removed from the back of each rabbit (20-30% of the body surface) with an electric clipper. The skin of one male and one female was abraded by making shallow incisions with a scalpel blade, not sufficiently deep to cause bleeding. The test material was applied once only to the backs of the rabbits at a dosage level of 20,000 mg/kg using 0.9% Physiological Saline as the wetting agent.

The area of application was wrapped with gauze bandaging and occluded with Saran Wrap. Twenty-four hours later the bandages were removed and the backs were washed with tepid tap water. They were observed at 24 hours and daily thereafter for a total of 14 days for mortality and pharmacotoxic signs.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test material identified as 'Firemaster 100 Lot 53 77.902' and was received as a fine white powder.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
Kuiper's Rabbit Ranch, Gary, Indiana.

- Age at study initiation:
Not reported.

- Weight at study initiation:
2308-2370 grams

- Fasting period before study:
Not applicable.

- Housing:
Animals were individually housed in metal metabolism cages in temperature and humidity controlled quarters.

- Diet (e.g. ad libitum):
Ad libitum

- Water (e.g. ad libitum):
Ad libitum

- Acclimation period:
Not reported.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
Not reported.

- Humidity (%):
Not reported.

- Air changes (per hr):
Not reported.

- Photoperiod (hrs dark / hrs light):
Not reported.

IN-LIFE DATES: From: day 1 To: day 15

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: 0.9% Physiological Saline
Details on dermal exposure:
TEST SITE
- Area of exposure:
20-30% of the body surface.

- % coverage:
Not reported.

- Type of wrap if used:
The area of application was wrapped with gauze bandaging and occluded with Saran Wrap.

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Yes

- Time after start of exposure:
Twenty-four hours after the commencement of the exposure the bandages were removed and the backs were washed with tepid tap water.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
20,000 mg/kg

- Concentration (if solution):
Not applicable.

- Constant volume or concentration used:
yes

- For solids, paste formed:
yes, the test material was applied once only to the backs of the rabbits at a dosage level of 20,000 mg/kg using 0.9% Physiological Saline as the wetting agent.

VEHICLE
Not applicable.
Duration of exposure:
24 hours.
Doses:
20,000mg/kg
No. of animals per sex per dose:
2 males and 2 females
Control animals:
no
Details on study design:
- Duration of observation period following administration:
14 days

- Frequency of observations and weighing:
The animals were observed at daily during the 14 days following the exposure for mortality and pharmacotoxic signs. Body weights were measured at 7 and 14 days

- Necropsy of survivors performed:
no

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
None reported.
Statistics:
Not reported.

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 20 000 mg/kg bw
Remarks on result:
other: 95% CL not reported.
Mortality:
None of the rabbits died during the 14-day observation period. The minimum lethal dose by the dermal route of administration was found to be greater than 20,000 mg/kg.
Clinical signs:
No treatment related signs were noted in the test animals.
Body weight:
See table 1.
Gross pathology:
Not applicable.

Any other information on results incl. tables

Table 1: Bodyweights.

Dosage

Level

mg/kg

Individual

Rabbit No.

Sex

Control

Weight

(grams)

7-Day

Weight

(grams)

14-Day

Weight

(grams)

20000

28969

Male

2370

2302

2375

 

28979

Male

2310

2362

1800

 

28950

Female

2308

2331

2297

 

28984

Female

2325

2233

2144

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The minimum lethal dose by the dermal route of administration was found to be greater than 20,000mg/kg.
Executive summary:

Two male and 2 female New Zealand White rabbits were used for this study.

The hair was removed from the back of each rabbit (20-30% of the body surface) with an electric clipper. The skin of one male and one female was abraded by making shallow incisions with a scalpel blade, not sufficiently deep to cause bleeding. The test material was applied once only to the backs of the rab­bits at a dosage level of 20,000 mg/kg using 0.9% Physiological Saline as the wetting agent.

None of the rabbits died during the 14-day observation period. The minimum lethal dose by the dermal route of administration was found to be greater than 20,000 mg/kg.