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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

Constituent 1
Chemical structure
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 peracetate

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 levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
4 000 mg/kg bw
Based on:
test mat.
95% CL:
2 000 - 8 000
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
5 657 mg/kg bw
Based on:
test mat.
95% CL:
2 828 - 11 314
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:
see any other information on results
Body weight:
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 in the section any other information on results.

Any other information on results incl. tables

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

Table 1:

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:

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:
not classified
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).