Sodium p-chloro-m-cresolate

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: The test material was administered to male rats orally to assess acute oral toxicity.
- Short description of test conditions: Ten animals per dose group were orally administered six doses of the test substance in Lutrol as vehicle as a single dose via gavage. Animals were observed for 14 days.
- Parameters analysed / observed: mortality, clinical signs, necropsy, body weights

GLP compliance:

no

Test type:

other: acute oral toxicity

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium p-chloro-m-cresolate

EC Number:

239-825-8

EC Name:

Sodium p-chloro-m-cresolate

Cas Number:

15733-22-9

Molecular formula:

C7H6ClNaO

IUPAC Name:

sodium 4-chloro-3-methylphenolate

1

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Test material form:

solid

Test animals

Species:

rat

Strain:

other: Wistar TNO W 74

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: 176 g (average weight)
- Housing: 5 animals per sex in Makrolon cages, type III, on dust-free wood granules
- Diet: R 1324 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 1.5
- Humidity (%): 60 + 5
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Lutrol

Details on oral exposure:

VEHICLE
- Amount of vehicle:20 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

1000, 1300, 1500, 2000, 2500 and 3100 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 made several times on the day of treatment and twice daily (once daily on weekends and holidays) for 14 days after treatment. The animals were weighed at the start and at the end of the 14 day observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Probit analysis according to Fink and Hund for calculation of the LD50 value with the practical limit of error for p ≤ 0.05

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

1 610 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 390 - <= 1 850

Mortality:

1000 mg/kg bw: no mortalities occurred
1300 mg/kg bw: 3/10 animals died (8 h after application)
1500 mg/kg bw: 6/10 animals died (4/10 animals 2 h after application, 1/10 animal 4 h after application, 1/10 animal 24 h after application)
2000 mg/kg bw: 6/10 animals died (2/10 animals 1 h after application, 4/10 animals 2 h after application)
2500 mg/kg bw: 9/10 animals died (8/10 animals 2 h after application, 1/10 animal 4 h after application)
3100 mg/kg bw: 10/10 animals died (3/10 animals before 1 h after application, 4/10 animals 1 h after application, 1/10 animals 2 h after application, 2/10 animal 4 h after application)

Clinical signs:

other: 1000 mg/kg bw: No clinical signs of toxicity were observed up to the end of the 14-day observation period. 1500, 2000, 2500 and 3100 mg/kg bw: Clinical signs included narcosis, laying flat on their bellies, trembling and general reduction of well being. T

Gross pathology:

Necropsy revealed no substance-related findings.

Any other information on results incl. tables

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

Dose [mg/kg bw]	Mortality*	Time of death	Clinical signs*
1000	0/10	-	0/10
1300	3/10	8 h	10/10
1500	6/10	2 – 24 h	10/10
2000	6/10	1 – 2 h	10/10
2500	9/10	2 – 4 h	10/10
3100	10/10	< 1 – 4 h	10/10

* number of animals/ 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, 1300, 1500, 2000, 2500 and 3100 mg/kg bw test substance as a solution in Lutrol 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 14-day observation period. Surviving animals were weighed at the start and at the end of the observation period. Animals found dead and animals sacrificed at study termination were selectively dissected. No mortalities or clinical signs occurred at the lowest dose group. All animals died in the highest dose group between < 1 - 4 h after application. Mortalities of animals treated with 1300, 1500, 2000 and 2500 mg/kg bw (3/10 animals, 6/10 animals, 6/10 animals and 9/10 animals, respectively) occurred between 1 and 24 h post-dosing. The clinical signs observed in all animals from 1300 mg/kg bw were narcosis, lying flat on their bellies, trembling, and general reduction of well-being. The signs were fully reversible within 3 days post-administration up to 2000 mg/kg bw/day. At 2500 mg/kg bw 1/10 animal showed clinical signs up to the end of the 14 day observation period. Under the conditions of this study the LD50 was calculated to be 1610 mg/kg bw for male rats. According to Regulation (EC) No 1272/2008 the test material needs to be classified with Acute Tox. 4; H302: Harmful if swallowed.