3-chloroperbenzoic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Main test was started on May 18, 1987 and terminated on June 1, 1987.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

other: OECD 401: Acute oral toxicity

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-chloroperbenzoic acid

EC Number:

213-322-3

EC Name:

3-chloroperbenzoic acid

Cas Number:

937-14-4

Molecular formula:

C7H5ClO3

IUPAC Name:

3-chlorobenzene-1-carboperoxoic acid

Test material form:

liquid - solid: mixture of

Remarks:

The substance in its marketed form is not in solid or granular form. The marketed product contains 18% water and is thus a wet, paste-like consistency.

Specific details on test material used for the study:

The specific details on the test material used for this study were as follows:
A 100 g sample of the test substance was received from the sponsor on April 9, 1987.
Batch number: 04.87.03.0067.

The chemical and physical properties were stated to be:
Content of active ingredient: 48.9 %
Diluting agent: water, 43.8 %
Nature and quantity of impurities: m-chlorobenzoic acid, 7. 3 %
Melting point: about 363 °K
Density: bulk- about 610 kg/m^3

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test animals:
Young adult, about 9 weeks old, albino rats were used. They were Wistar outbred rats (Bor:WISW) obtained from a colony, maintained under SPFconditions at the Breeding Centre for Laboratory Animals, F. Winkelmann GmbH, Borchen, F.R. Germany. The body weights of the males varied from 188 to 237 g, those of the females from 132 to 160 g. The animals were kept under the environmental conditions of the Institute's animal house for about 3 weeks prior to the test.

Housing and maintenance:
The rats were housed in groups of five, males and females separated, in stainless steel cages with wire-screen bottom and front, in a room ventilated with about 10 air changes per hour and maintained at 22 ± 2°C. Relative humidity was between 40 and 60 per cent, lighting was artificial with a sequence of 12 hours light, 12 hours dark. Tap water was freely available at all times by means of an automatic watering system. The rats had free access to the Institute's cereal based, open formula diet for rats and mice, except in the overnight period before treatment till 4 hours after treatment when food was withheld. The diet is analyzed regularly for nutrients and contaminants. Tap water is analyzed regularly for contaminants.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test substance was given orally by gavage as an aqueous suspension in single doses of 1200, 1440, 1730, 2080 or 2500 mg substance per kg body weight to groups of 5 males and 5 females. For each dose level a suspension was prepared to administer a constant volume of 10 ml/kg body weight to all rats.

Doses:

1200, 1440, 1730, 2080 or 2500 mg substance per kg body weight

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

not specified

Details on study design:

After treatment, the rats were observed frequently for signs of intoxication during the first 4 hours and thereafter, at least once daily throughout an observation period of 14 days. The individual body weights of the rats were recorded on day 0, 7 and 14. At the end of the observation period, the surviving rats were killed and examined grossly.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 807 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 457 - <= 2 241

Mortality:

Deaths occurred between 6 hours and 3 days after dosing.

Number of mortalities per dose per group:
At 1200 mg/kg bw: males = 0 females = 2
At 1440 mg/kg bw: males = 0 females = 3
At 1730 mg/kg bw: males = 0 females = 3
At 2080 mg/kg bw: males = 3 females = 5
At 2500 mg/kg bw: males = 3 females = 4

Clinical signs:

other: Within a few hours after treatment, the rats showed sluggishness, piloerection and pallor discolouration of the skin. Later on encrustations around eyes and nostrils were observed. Signs of tremors or phonation were observed in a few rats.

Gross pathology:

Macroscopic examination at autopsy of the rats did not reveal any treatment related gross alteration.

Other findings:

After treatment with the test substance, the survivors recovered and looked quite healthy throughout the remaining part of the observation period.

Any other information on results incl. tables

Dose applied and mean body weights of each group at Days 0, 7 and 14:

Dose		Mean body weight (g) on Day
		Males			Females
Suspension (ml/kg)	Substance (mg/kg)	0	7	14	0	7	14
10.0	2500	210	243	282	148	151	191
10.0	2080	217	231	272	144	-	-
10.0	1730	215	227	240	147	171	188
10.0	1440	218	240	254	139	147	169
10.0	1200	213	234	253	143	156	176

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

LD50 = 1807 mg/kg BTW

Conclusions:

The oral LD50 of m-chloroperoxybenzoic acid was calculated to be 1807 mg per kg body weight with 1457 and 2241 as the 95% confidence limits. Therefore, the test substance can be classified as slightly toxic (Hodge, H.C. and J.H. Sterner, Ind. Hyg. Assoc. Quart. 10 (1949) 93) .

Executive summary:

1. The acute oral toxicity of m-chloroperoxybenzoic acid was examined in rats.

2. The test substance was given by gavage as aqueous suspensions in single doses of 1200, 1440, 1730, 2080 or 2500 mg per kg body weight to groups

of 5 males and 5 females.

3. Within a few hours after treatment, the rats showed sluggishness, piloerection and pallor discolouration of the skin. Later on encrustations around eyes and nostrils were observed. Signs of tremors or phonation were observed in a few rats. Deaths occurred between 6 hours and 3 days after dosing. Then the survivors recovered and looked quite healthy throughout the remaining part of the observation period.

4. The oral LD50 of the test substance was calculated to be 1807 mg per kg body weight with 1457 and 2241 as the 95% confidence limits.