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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
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): KMC 113/1, Alkylnaphthalin
- Physical state: colorless liquid
- Analytical purity: no data
- Isomers composition: no data
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: four to seven weeks
- Weight at study initiation: males 245 - 255 g, females 205 - 225 g
- Fasting period before study: no data
- Housing: singly in Makrolon-cages with bedding
- Diet (e.g. ad libitum): R 4 complete rat diet (Ssniff Versuchstier-Diäten GmbH, Soest, Germany), ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 40 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 /12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: ca 34 cm²
- % coverage: ca. 10% of body surface
- Type of wrap if used: occlusive wrap (Leukoplast)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance residues were washed off with water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4500 mg/kg
- Concentration (if solution): pure test substance
Duration of exposure:
24 hours
Doses:
4500 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: 0.25, 0.5, 1, 2, and 4 hours after TS administration, daily thereafter;
weighing: at days -1, 0 (day of administration), 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
no calculations

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 500 mg/kg bw
Remarks on result:
other: only one dose administered (limit test); no mortality
Mortality:
No mortality
Clinical signs:
No clinical signs
Gross pathology:
No macroscopic findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute dermal toxicity test using only one dose (4500 mg/kg bw, limit test), 5 rats/sex were exposed to KMC 113/1 (diisopropylnaphthalene) for 24 hours. No mortality and no clinical or gross pathological findings were observed. The LD50 for acute dermal toxicity can be assessed to be >4500 mg/kg bw under the conditions of this test.