tert-butyl peracetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978-08-23 and 1978-12-15

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

2 animals per doses per sex

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl peracetate

EC Number:

203-514-5

EC Name:

tert-butyl peracetate

Cas Number:

107-71-1

Molecular formula:

C6H12O3

IUPAC Name:

tert-butyl ethaneperoxoate

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: H.A.R.E. Rabbits for Research, Hewitt, New Jersey
- Weight at study initiation: 2304 to 2863 grams
- Housing: individually housed in hanging wire-mesh cages
- Diet: Purina® Rabbit Chow®; ad libitum
- Water: ad libitum
- Acclimation period: 19 days

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
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 in each group was abraded with a scalpel blade by making 10 cm long epidermal abrasions every 2 or 3 cm longitudinally over the area of exposure. Following dosing, the application sites were wrapped with gauze bandaging and overwrapped with Saran Wrap. The entire application area was then wrapped with several layers of 75 mm Elastoplast tape. A collar was also applied.

REMOVAL OF TEST SUBSTANCE
- 24-h following application, the bandages and collars were removed and the test sites were wiped clean

Duration of exposure:

24 hours

Doses:

500, 1000, 2000, 4000, 8000 and 16000 mg/kg

No. of animals per sex per dose:

2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: rabbits were observed for mortality twice daily for a total of 14 days
- Frequency of weighing: immediately prior to test material administration (control weight) and at 7 and 14 days of the observation period

Statistics:

95% confidence limits

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

4 000 mg/kg bw

Based on:

test mat.

95% CL:

2 000 - 8 000

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

5 657 mg/kg bw

Based on:

test mat.

95% CL:

2 828 - 11 314

Effect levels 3

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 757 mg/kg bw

Based on:

test mat.

95% CL:

3 364 - 6 727

Mortality:

Please refer to Table 1 ("Any other information on results incl tables")

Body weight:

other body weight observations

Remarks:

The body weight gain of two females was slightly reduced between day 7 and 14. Two other females lost weight between day 1 and 14. One male showed a very slight lost of weight between day 1 and 7. The body weights of all animals are shown in Table 2 (refer to "Any other information on results incl tables").

Any other information on results incl. tables

Table 1 shows the number of deaths during the observation period.

Table 1: Summary of Mortality

Time of observation

Number of Deaths

Dosage Level (mg/kg)

500

1000

2000

4000

8000

16000

M

F

M

F

M

F

M

F

M

F

M

F

Day 1

2

1

2

1

Day 2

1

1

Day 3 -14

Total

0/2

0/2

0/2

0/2

0/2

0/2

1/2

0/2

2/2

2/2

2/2

2/2

M: male

F: female

 

Table 2 shows the body weights obtained during the observation period.

 

Table 2: Summary of body weight measurements

Dosage Level (mg/kg)	Animal + Sex	Control Weight (g)	7 Day Weight (g)	14 Day Weight (g)
500	01 Male	2304	2441	2841
	02 Male	2512	2668	2761
	01 Female	2525	2731	3088
	02 Female	2852	2939	3131
1000	03 Male	2545	2706	2841
	04 Male	2429	2442	2530
	03 Female	2693	2732	2611
	04 Female	2485	2505	2981
2000	05 Male	2310	2421	2733
	06 Male	2863	2841	2889
	05 Female	2742	2886	2863
	06 Female	2358	2205	1971
4000	07 Male	2470	2460	2581
	08 Male	2320	died	died
	07 Female	2633	2565	2911
	08 Female	2569	2211	2423
8000	09 Male	2480	died	died
	10 Male	2402	died	died
	09 Female	2451	died	died
	10 Female	2325	died	died
16000	11 Male	2326	died	died
	12 Male	2467	died	died
	11 Female	2310	died	died
	12 Female	2308	died	died

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based upon the data obtained, the acute dermal LD50 values and 95% confidence limits for the test material (75% active ingredient) were calculated to be as follows: Male Rabbits: 4000 (2000 - 8000) mg/kg bw, Female Rabbits: 5657 (2828 - 11314) mg/kg bw, Combined Male and Female Rabbits: 4757 (3364 - 6727) mg/kg bw. Based on the mixture containing 50% of the active ingredient the dermal LC50 values are expected to be 6000 mg/kg bw (males), 8485.5 mg/kg bw (females) and 7135.5 mg/kg bw (combined male and female).

Executive summary:

An acute dermal toxicity study was performed in 12 male and 12 female New Zealand White rabbits obtained from H.A.R.E. Rabbits for Research, Hewitt, New Jersey.They were individually housed in hanging wire-mesh cages and water and diet were available ad libitum. The rabbits were divided into six groups of two male and two female rabbits each. The test material (75% active ingredient) was applied once only to the backs of the rabbits at the following dosage levels: 500, 1000, 2000, 4000, 8000 and 16000 mg/kg bw. Following dosing, the application sites were wrapped with gauze bandaging and overwrapped with Saran Wrap. The entire application area was then wrapped with several layers of 75 mm Elastoplast tape. The animals were durated for 24 hours. The mortality was checked twice daily for a period of 14 days. The body weight gain were recorded immediately prior to test material (control weight) and on day 7 and 14.

Based upon the data obtained, the acute dermal LD50 values and 95% confidence limits were calculated to be as follows: Male Rabbits: 4000 (2000 - 8000) mg/kg bw, Female Rabbits: 5657 (2828 - 11314) mg/kg bw, Combined Male and Female Rabbits: 4757 (3364 - 6727) mg/kg bw. Based on the mixture containing 50% of the active ingredient the dermal LC50 values are expected to be 6000 mg/kg bw (males), 8485.5 mg/kg bw (females) and 7135.5 mg/kg bw (combined male and female).