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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
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): 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 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