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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was performed similar to OECD guideline 402 but performance criteria and results are not reported in detail. Quality criteria requested by actual guidelines have not been met.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Amount of naphthalene applied was 16,000 mg/kg body weight instead of 2,000 mg/kg body weight
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): Naphthalene Nr. 104.111 from Rütgerswerke AG, Duisburg.
- Physical state: solid, granular
- Analytical purity: pure, 79.6°
- Impurities (identity and concentrations): none reported
- Stability under test conditions: stable

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: W. Gassner, Sulzfeld
- Weight at study initiation: male 120 - 155 g; female 125 - 165 g
- Housing: air-conditioned cages, 5 animals per cage
- Diet (e.g. ad libitum): Ssniff (Pellets)
- Water (e.g. ad libitum): water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-1 °C
- Photoperiod (hrs dark / hrs light): 12 hour day-night-rhythm

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back/flank

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16,000 mg/kg body weight
- For solids, paste formed: no
Duration of exposure:
24 hours
Doses:
16,000 mg/kg body weight
No. of animals per sex per dose:
5 per sex
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, pathoanatomical findings
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred in 13 days post exposure.
Clinical signs:
One female animal showed very slight oedema.
Body weight:
Changes of body weight of animals exposed to naphthalene were in the normal range compared with the control group.
Gross pathology:
All animals were without pathoanatomical findings.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD 50 (acute dermal application) > 16,000 mg/kg body weight based on the negative results of this study.
Executive summary:

The study was performed similar to the proceedings prescribed for the limit test on acute dermal toxicity by OECD guideline 402 with the exemption that the amount of naphthalene applied to the laboratory animals (16,000 mg/kg bw) was much higher than stipulated by the OECD guideline (2,000 mg/kg). Results are not documented in the report in detail (e.g. changes in behaviour), but no mortality occurred during the 13 days observation period after a 24 hour dermal application of 16,000 mg/kg naphthalene. No significant changes in body weight have been observed within the observation period and all animals were without pathoanatomical findings. The study has been performed similar to actual OECD guidelines and therefore, the results are regarded to be reliable. Thus, naphthalene can be regarded as being practically nontoxic via the dermal route. Furthermore, due to only one out of ten test animals showing slight oedema, naphthalene can be regarded as not being corrosive or irritating.