Xylenol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

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 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

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

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
- Structural formula attached as image file (if other than submission substance): see Fig.
- 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:

TEST ANIMALS
- Source: Dr. A. Ivanovas, Kisslegg/Allgäu/Germany
- Age at study initiation: no data
- Weight at study initiation: 210 - 235 g (male); 200 - 230 g (female)
- Fasting period before study: no
- Housing: 1 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

Type of coverage:

occlusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: 5 cm x 7.5 cm, shaved, intact skin
- Administration: Dosing in dissolved form by syringe (at elevated temperature to prevent precipitation)
- Type of wrap: thin aluminum foil covering the treated area and adhesive bandage ("Elastoplast") round the trunk
-

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3 mL/kg bw of test solution (highest test volume technically achievable on the skin area)
- Concentration (if solution): 80 % in PEG 300
- Constant volume or concentration used: yes
- For solid: dissolved in PEG at 50 °C, at lower temperature precipitation

Duration of exposure:

24 h

Doses:

2400 mg/kg bw (3,5-xylenol)
[Note: In report 2.4 mL/kg is mentioned, but not conclusive as 80 % solution of the solid test substance in PEG should relate to w/v. 3 mL solution/kg were applied => 80% (w/v) = 2.4 g/kg.]

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Details on study design:

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

Statistics:

not applicable

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 400 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 400 mg/kg bw

Mortality:

none

Clinical signs:

other: no particular observations

Gross pathology:

no skin reactions (effects scores = 0) ; no particular findings at organs

Other findings:

none

Any other information on results incl. tables

No clinical signs of toxicity reported up to 2400 mg/kg

Applicant's summary and conclusion

Conclusions:

No clinical signs of toxicity reported up to 2400 mg/kg