Naphthalene

Acute Toxicity: dermal

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

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

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 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 or test system 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:

other: One female animal showed very slight oedema.

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.