Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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:
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:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 400 mg/kg bw
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 400 mg/kg bw
Mortality:
none
Clinical signs:
no particular observations
Body weight:
no significant differences from the control groups
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