4-chlorophenol

Acute Toxicity: oral

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: Comparable to guideline study with acceptable restrictions (analytical purity not reported)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

analytical purity not reported

GLP compliance:

no

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

Details on test material:

- Name of test material (as cited in study report): p-chlorophenol
- Analytical purity: not reported
- Lot/batch No.: 2287

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation: 150-200 g
- Fasting period before study: animals were fasted from approximately 16 hours before until 2 hours after the treatment
- Housing: in Makrolon cages Type II or III
- Diet: Altromin-R-Haltungsdiät for rats and mice, ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Lutrol

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 0.5 mL/100 g bw

Doses:

100, 500, 750, 1000, 1500, 2000, and 2500 mg/kg bw (males)
100, 250, 500, 600, 750, 1000, 1250, 1750, 2000 mg/kg bw (females)

No. of animals per sex per dose:

10

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

The calculation of the LD 50 with the confidence limit for p=0.05 was conducted by means of the Probit-Analysis.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1 258 mg/kg bw

Based on:

test mat.

95% CL:

1 044 - 1 502

Remarks on result:

other: b (regression coefficient) =5.92

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 988 mg/kg bw

Based on:

test mat.

95% CL:

841 - 1 164

Remarks on result:

other: b (regression coefficient)= 5.63

Mortality:

600 mg/kg bw: 2/10 females died
750 mg/kg bw: 1/10 males and 3/10 females died
1000 mg/kg bw: 3/10 males and 4/10 females died
1250 mg/kg bw: 7/10 females died
1500 mg/kg bw: 7/10 males died
1750 mg/kg bw: 9/10 females died
2000 mg/kg bw: 8/10 males and 10/10 females died
2500 mg/kg bw: 10/10 males died

Clinical signs:

> 250 mg/kg bw: 10/10 female and animals show toxicological symptoms

The following symptoms of poisoning occurred about 5 minutes after treatment: general behaviour disturbances (apathy), dyspnoea, convulsions, tremors and abdominal and lateral positions.
Dyspnoea, cramps, abdominal and lateral positions were observed in the treatment of live animals up to 24 hours and the disturbance of general condition of up to 6 days after treatment

Body weight:

No effect on body weight was noted

Gross pathology:

The following post mortem findings were noticeably: pale and spotted livers, spleens and kidneys and emphysematous lungs changes. In the surviving treated animals no pathological changes were found.

Any other information on results incl. tables

Table 1. Table for acute oral toxicity

Dose [mg/kg bw]	Toxicological results*	Time of death	LD 50 (14 Days) mg/kg bw
Males
100	0/0/10	---	1258 (1044-1502)
500	0/10/0	---
750	1/10/10	1h 13´
1000	3/10/10	2h 32´
1500	7/10/10	1h 30´-4 h 20´´
2000	8/10/10	15´-24 h
2500	10/10/10	50´- 4h 20´´
Females
100	0/10/10	---	988 (841- 1164)
250	0/10/10	---
500	0/10/10	---
600	2/10/10	1h 40´
750	3/10/10	2h 15´- 24h
1000	4/10/10	1h 5´- 2h 17´
1250	7/10/10	32´- 2h 47´
1750	9/10/10	20´- 4h 20´
2000	10/10/10	30´- 24h

 * first number = number of dead animals                                   

 second number = number of animals with clinical signs           

 third number = number of animals used                                 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: Acute Tox. 4, H302
DSD: Xn, R22