Mono-, and di-(sec-hexadecyl)naphthalene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report similar or equivalent to OECD 401.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Mono-, and di-(sec-hexadecyl)naphthalene

EC Number:

930-936-3

Molecular formula:

C26H40 + C42H72

IUPAC Name:

Mono-, and di-(sec-hexadecyl)naphthalene

Details on test material:

- Name of test material (as cited in study report): MCP 917
- Physical state: homogeneous liquid
- Expiration date of the lot/batch: 04/01/1994
- Stability under test conditions: 5 years at room temperature
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Taconic Farms, Germantown, NY
- Weight at study initiation: Male: 245-374g; Female: 189-270g
- Fasting period before study: overnight

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5 mg/kg

No. of animals per sex per dose:

5 per sex

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Signs of toxicity were recorded at ~ 1/2, 1 and 4 hours after study substance administration and daily thereafter with the exception of weekends. Body weights were recorded prior to fasting and on Days 0, 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, and gross pathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths following administration of the study substance.

Clinical signs:

other: There were several clinical observations noted in one or more animals: decreased activity, urogenital staining (yellow), anogenital staining (yellow-brown), chromodacryorrhea, and alopecia (forelimbs).

Gross pathology:

There were no treatment-related gross pathological changes.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the parameters of this study, the acute oral LD50 for the study substance is >5.0 g/kg in the rat. This finding does not warrant the classification as an acute oral toxicant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

In this study, ten rats were given a single 5.0 g/kg dose of the study substance by oral gavage. The rats were then observed for 14 days and a gross examination was performed at the termination of the study period. All animals survived to termination of the study period. There was an increase in mean and individual body weights in relation to the pre-fast body weights. Decreased activity, urogenital and anogenital staining, alopecia and chromodacryorrhea were observed in one or more animals. There were no treatment-related gross pathological changes. Based on the parameters of this study, the acute oral LD50 for the study substance is >5.0 g/kg in the rat. This finding does not warrant the classification of the study substance as an acute oral toxicant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.