A mixture of isomers of: mono-(2-tetradecyl)naphthalenes; di-(2-tetradecyl)naphthalenes; tri-(2-tetradecyl)naphthalenes

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402. GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of isomers of: mono-(2-tetradecyl)naphthalenes; di-(2-tetradecyl)naphthalenes; tri-(2-tetradecyl)naphthalenes

EC Number:

410-190-0

EC Name:

A mixture of isomers of: mono-(2-tetradecyl)naphthalenes; di-(2-tetradecyl)naphthalenes; tri-(2-tetradecyl)naphthalenes

Cas Number:

132983-41-6

Molecular formula:

Can vary from C24H36 (mono rxn product) to C52H92 (tri rxn product)

IUPAC Name:

2,3,6-tritetradecylnaphthalene; 2,3-ditetradecylnaphthalene; 2-tetradecylnaphthalene

Details on test material:

MCP968 is a straw colored homogenous liquid. The MEHSL CRU number is 90163. This substance is stable for 6 months at 20C with an expiration date of 8/30/1990.

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Male and female young adult New Zealand White rabbits obtained from Hazleton Research Products, Inc. (Denver, Pa) were used in this study. The male body weights ranged from 2.2-2.8 kilograms and the female body weights ranged from 2.2-2.7 kilograms. The animals were identified by individual ear tags and cage cards. The temperature of the study room was maintained at 68-72F with a relative humidity of 41-61%.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The back of each animal was shaved prior to administration of the test substance. T he dose was applied evenly to the back of each animal followed by a layer of 8-ply gauze to cover the test site. The gauze was covered by a rubber dam and the anterior and posterior edges of the dam securely taped. A plastic Elizabethan collar was placed on each animal to prevent oral ingestion of the test substance and mechanical irritation of the test site.

Duration of exposure:

24h

Doses:

2gm/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

Following a 24 hour exposure period, the dam and gauze were removed and the residual test substance wiped from the site. Clinical observations were recorded at approximately 1 and 4 hours after test substance administration and daily thereafter except on weekends. The condition of each animal (live, dead, moribund) was checked at least once daily. T he study was terminated after 14 days and each animal necropsied.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: The following clinical obsrvations were noted in one or more animals: soft stool, decreased fecal output, diarrhea, decreased urinary output, and decreased food consumption.

Gross pathology:

There were no gross pathological findings noted at necropsy that could be related to treatment

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 for acute dermal toxicity of the submission substance is greater than 2000 mg/kg bw in the New Zealand White rabbit. This finding does not warrant classification of the test material as an acute dermal 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:

The test article was administered as a single dose for 24 hours to ten white rabbits at a concentration of 2000 mg/kg to assess acute dermal toxicity. Animals were observed for fourteen days following exposure. All animals survived to the termination of the study period. An increase in mean and individual body weights was observed during the study with the exception of one male that lost weight between days 7 adn 14. Soft stool, decreased fecal output, diarrhea, decreased urinary output and decreased food consumption were noted in one or more animals. There were no treatment-related gross pathological changes. Based on the conditions of this study, the dermal LD50 for the test material is greater than 2.0 gm/kg. This finding does not warrant classification of the test material as an acute dermal 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.