Isopropylnaphthalene

Acute Toxicity: dermal

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

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(isopropyl)naphthalene

EC Number:

254-052-6

EC Name:

Bis(isopropyl)naphthalene

Cas Number:

38640-62-9

Molecular formula:

C16H20

IUPAC Name:

Bis(isopropyl)naphthalene

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 or test system 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:

other: 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.