4-chlorophenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

April to June 1980

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Remarks:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail, test method comparable to guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

not specified

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-chlorophenol

EC Number:

203-402-6

EC Name:

4-chlorophenol

Cas Number:

106-48-9

Molecular formula:

C6H5ClO

IUPAC Name:

4-chlorophenol

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Remarks:

TNO/W 74

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Recognised animal supplier.
- Age at study initiation: Not reported.
- Weight at study initiation: 150 - 200 g
- Fasting period before study: Not reported
- Housing: Makrolon type III or II cages.
- Diet: Altromin-R maintenance diet for rats and mice, ad libitum.
- Water: 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.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

poloxamer

Remarks:

given by its alternative trade name "Lutrol" in study report.

Details on oral exposure:

Administered once via ,,Schlundsonde'' ("Gullet-tube"), i.e. oral gavage.

Doses:

100, 500, 750, 1000, 1500, 2000 and 2500 mg/kg bw (M); 100, 250, 500, 600, 750, 1000, 1250, 1750 and 2000 mg/kg bw (F).

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: At least once daily for 14 days.
- Necropsy of survivors performed: Yes.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

1 258 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

988 mg/kg bw

Based on:

test mat.

Mortality:

Mortalities occurred.

Clinical signs:

other: Poisoning symptoms occured about 5 minutes after treatment, including disturbances of general behaviour (apathy), laboured breathing, convulsions, tremors, and lying in prone/lateral positions. The symptoms persisted in surviving animals for up to 24 hour

Gross pathology:

Post-mortem examinations of mortalities indicated pale, spotted livers, spleen and kidneys. Empysematous lung-changes were also noticeable. No pathalogical features were found in surviving animals upon euthanisation at the end of the study period. (Translated from German).

Any other information on results incl. tables

Table 1: Acute oral toxicity in "soberly-handled" rats (translated from German)

Dose [mg/kg bw]	Toxicology Result [Dead / With Symptoms / Total Used]	Time of Death following Treatment	LD50 (14 -days) [mg/kg bw]
Male Rats
100	0/0/10*	-	1258 (1044 - 1502) b = 5.92**
500	0/10/10	-
750	1/10/10	1h 13'
1000	3/10/10	2h 32'
1500	7/10/10	1h 30' - 4h 20'
2000	8/10/10	0h 15' - 24h 0'
2500	10/10/10	0h 50' - 4h 20'
Female Rats
100	0/10/10*	-	988 (841 - 1164) b = 5.63**
250	0/10/10	-
500	0/10/10	-
600	2/10/10	1h 40'
750	3/10/10	2h 15' - 24h 0'
1000	4/10/10	1h 5' - 2h 10'
1250	7/10/10	0h 32' - 2h 47'
1750	9/10/10	0h 20' - 4h 20'
2000	10/10/10	0h 30' - 24h 0'

* Maximum dose without negative effects

** Regression coefficient

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

EU criteria met

Conclusions:

Under the conditions of this study the LD50 was determined to be 1258 mg/kg bw in the male Wistar rat and 988 mg/kg bw in the female Wistar rat.

Executive summary:

The study was performed following a method equivalent or similar to OECD TG 401 to assess the acute oral toxicity potential of the test substance to male and female Wistar rats. The test item was administered as a single dose via oral gavage to groups of 10 male and 10 female rats per dose-level orally. Under the conditions of this study the LD50 was determined to be 1258 mg/kg bw for male Wistar rats and 988 mg/kg bw for female Wistar rats.