2,3,6-trimethylphenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1969 (march 14-19, and may 13-30)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles; pre-GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

20 animals/dose

Principles of method if other than guideline:

BASF-Test

GLP compliance:

no

Remarks:

pre-GLP study

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,3,6-trimethylphenol

EC Number:

219-330-3

EC Name:

2,3,6-trimethylphenol

Cas Number:

2416-94-6

Molecular formula:

C9H12O

IUPAC Name:

2,3,6-trimethylphenol

Details on test material:

- Name of test material (as cited in study report): 2,3-6-Trimethyl-phenol (TMP)
Analytical purity: 99%

Test animals

Species:

rat

Strain:

other: Gassner

Sex:

male/female

Details on test animals or test system and environmental conditions:

day /night rhythmus 12/12h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous Traganth

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2, 16, and 30% (w/v)
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: no data

No further data.

Doses:

200, 1600, 3200, 3600, 4000, 5000, 6400 mg/kg bw

No. of animals per sex per dose:

20 animals per dose (10/sex)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily (observations); body weight males: 215-250g, female 174-200g
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 3 600 mg/kg bw

Remarks on result:

other: after 7 days; 95% CL not given

Mortality:

Deaths occurred at all dose levels with exception of the lowest dose (200 mg/kg bw); see table below.

Clinical signs:

6400-1600 mg/kg bw:
Squatting posture or prone/lateral position (immediately after dosing), calm behaviour, accelerated or superficial respiration, piloerection, moderate secretion of the buccal cavity, masticatory movements, extended hind limbs, apathy, and weak tonus were observed in these groups.
At 5000 and 4000 mg/kg bw, narcosis was observed after approximately 15 minutes. At the day after dosing, surviving animals of these two dose groups exhibited intermittent respiration and piloerection.
The remaining animals were normal by days 3-4.

200 mg/kg bw:
No clinical symptoms were observed.

Body weight:

no data

Gross pathology:

Decedents:
hydrothorax (17 rats)
serous adhesions at the snout (14 rats)
plethora and serosa of the pleura (21 rats)
deposits of the test material in the stomach (2 rats)

Survivors: no pathological changes of the organs

Any other information on results incl. tables

Mortality rates after 1, 24, and 48 hours and after 7 days

Dose [mg/kg]	conc. [%]	no. of rats	1 h	24 h	48 h	7 d
6400	30	20	0/20	19/20	19/20	19/20
5000	30	20	0/20	20/20	20/20	20/20
4000	30	20	0/20	15/20	16/20	16/20
3600	30	20	0/20	7/20	9/20	9/20
3200	30	20	0/20	6/20	6/20	6/20
1600	16	20	0/20	3/20	3/20	3/20
200	2	20	0/20	0/20	0/20	0/20

Applicant's summary and conclusion

Executive summary:

10 male and 10 female rats were administered the test substance orally and were observed for 7 days. The acute oral LD50 was 3600 mg/kg bw for both males and females.