3,5-xylenol

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: Study in compliance with specific test guidelines, well documented, acceptable for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to same study

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)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,5-xylenol

EC Number:

203-606-5

EC Name:

3,5-xylenol

Cas Number:

108-68-9

Molecular formula:

C8H10O

IUPAC Name:

3,5-dimethylphenol

Constituent 2

Reference substance name:

3,5 dimethylphenol

IUPAC Name:

3,5 dimethylphenol

Details on test material:

- Name of test material (as cited in study report): Produkt-Nr. 111.184 (= 3,5-dimethyl phenol)
- Molecular formula (if other than submission substance): C8H10O
- Substance type: organic
- Physical state: solid
- Analytical purity: specified as "pure"
- Impurities (identity and concentrations): no data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

EST ANIMALS
- Source: Dr. A. Ivanovas, Kisslegg/Allgäu/Germany
- Age at study initiation: no data
- Weight at study initiation: 110 - 135 g (male); 110 - 125 g (female)
- Fasting period before study: 16
- Housing: 5 per cage
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Air-conditioned room
- Temperature (°C): 22 +-1 °C
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE (PEG 300)
- Amount of vehicle (if gavage): 10 mL minus test-substance volume

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2150, 3160, 4640, and 6810 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several-fold on day of application, thereafter daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Probit analysis according to Finney 1971

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 620 mg/kg bw

95% CL:

2 410 - 5 070

Mortality:

see below: Remarks on results...

Clinical signs:

other: piloerection, ventral or dorsal position, sedation; in addition, at the two higher doses: hunched posture, pallor of the extremities, twitches

Gross pathology:

Dose-related increase in reddening of the gastric mucosa from slight to severe, intestinal haemorrhage in animals of the second dose-group and higher, congestion in liver and spleen

Any other information on results incl. tables

MORTALITY Dose [mg/kg bw] Mortality (14 d) male female 0 (PEG 300) 0/5 0/5 2150 1/5 2/5 3160 1/5 2/5 4640 4/5 2/5 6810 4/5 5/5