Distillates (coal tar), naphthalene oil crystn. mother liquor

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Naphthalene

EC Number:

202-049-5

EC Name:

Naphthalene

Cas Number:

91-20-3

Molecular formula:

C10H8

IUPAC Name:

Naphthalene

Details on test material:

- Name of test material (as cited in study report): Naphthalene 79.6
- Ref.-No. 544 C 89
- Physical state: white powder
- Melting point: 79.6 °C
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Storage condition of test material: room temperature
- Fraction in Naphthalene oil: > 35 %

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa-Crédo, L'Arbresle, France
- Age at study initiation: 5 to 7 weeks
- Weight at study initiation: 127 - 156 g (the individual weights for each sex were within the range of 20% of the mean weights)
- Fasting period before study: yes (ca. 18 h)
- Housing: Animals were housed by sex in groups of 5 in type MI polycarbonate cages
- Diet: ad libitum, except fasting period and until 4 h post-treatement
- Water: ad libitum
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 - 70
- Air changes (per hr): at least 10 per hour
- Photoperiod (hrs dark / hrs light): 12 / 12 (photoperiod 7:30 -19:30)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

1 % (w/v)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20.0% (w/v)
- Amount of vehicle (if gavage): approx. 8 mL/kg
- Justification for choice of vehicle: no data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2000 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: four times at the day of intubation, then daily for 14 days; weighing: at day -1, day 1 (before administration of test substance), day 8 and day 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

1/10 animals died on day 2 (female)

Clinical signs:

All animals showed subdued behavior at 1, 2, and 4 hours after treatment. All other rats were normal on day 10.

Body weight:

surviving animals: normal

Gross pathology:

No particular findings

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU