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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: reporting deficiencies, no purity provided

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
no guideline followed
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1987
Deviations:
yes
Remarks:
environmental conditions and pathology findings not reported, only male rats, acclimatisation period of 3 instead of 5 days
Principles of method if other than guideline:
In fact no guideline was reported in the study; the test conduct, however, was in principle similar to the OECD TG 401.
GLP compliance:
no
Test type:
other: acute oral toxicity
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Chlorocresol
EC Number:
200-431-6
EC Name:
Chlorocresol
Cas Number:
59-50-7
Molecular formula:
C7H7ClO
IUPAC Name:
4-chloro-3-methylphenol

Test animals

Species:
rat
Strain:
other: Wistar (Strain Bor: WISW (SPF Cpb))
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: young adult
- Weight at study initiation: 160 - 180 g
- Housing: 5 animals per cage
- Acclimation period: 3 days

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Doses:
1000, 1500, 2000, 3150, 3100 and 5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were conducted on the day of treatment and twice each working day and once daily on weekends. Surviving animals were weighed before treatment, after one week and at study termination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
1 830 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 470 - <= 2 260
Mortality:
1500 mg/kg bw/day: 4/10 males died (2 - 7 d post-dose)
2000 mg/kg bw/day: 7/10 males died (3 h - 2 d post-dose)
3100 mg/kg bw/day: 8/10 males died (3 h - 2 d post-dose)
5000 mg/kg bw/day: 10/10 males died (1 h post-dose)
Clinical signs:
other: all animals in all dose groups: increased diuresis, sedation, respiratory disturbance, side position, tremor and tonical cramps
Gross pathology:
Not specified.

Any other information on results incl. tables

Table 1: Results of acute oral toxicity testing in male rats

Dose [mg/kg bw]

Toxicological results*

Time of death

Mortality (%)

1000

0/10/10

-

0

1500

4/10/10

2 d - 7 d

40

2000

7/10/10

3 h - 2 d

70

3100

8/10/10

3 h - 2 d

80

5000

10/10/10

1 h

100

* number of dead animals/ number of animals with signs of toxicity/ number of animals used

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
CLP: Acute Oral 4, H302
Executive summary:

A study for acute oral toxicity in the rat was conducted with the test substance. 10 male Wistar rats per group received 1000, 1500, 2000, 3100 and 5000 mg/kg bw test substance as a solution in Polyethyleneglycol 400 as vehicle by single-dose oral gavage. Observations were made frequently on the day of treatment and twice each working day and once daily on weekends throughout the two-week observation period. Surviving animals were weighed before treatment, after one week and at study termination. Pathological-anatomical examinations were performed on all animals. The clinical signs observed were increased diuresis, sedation, respiratory disturbance, side position, tremor and tonical cramps. All animals died in the highest dose group within 1 h after application. Mortalities of animals at the dose groups 2000 and 3100 mg/kg bw/day (7/10 and 8/10 males died, respectively) occurred between 3 h and 2 d post-dosing. 4/10 animals died at 1500 mg/kg bw at 2 – 7 d after test substance administration. No mortalities occured at 1000 mg/kg bw/day. Clinical signs in all animals at all dose groups included increased diuresis, sedation, respiratory disturbance, side position, tremor and tonical cramps. Under the conditions of this study the LD50 was considered to be 1830 mg/kg bw for male rats. According to Regulation (EC) No 1272/2008 the test material needs to be classified with respect to the oral route with Acute Tox. 4; H302.