Amides, tall-oil fatty, N,N-di-Me

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Older proprietary study, limited reporting and not comparable to current guidelines but adequate for the purposes of hazard assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The study was conducted prior to development of the guidelines. Two rabbits per dose were evaluated for 2 weeks following a 24 hour exposure.

GLP compliance:

no

Remarks:

study conducted prior to development of GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amides, tall-oil fatty, N,N-di-Me

EC Number:

269-665-4

EC Name:

Amides, tall-oil fatty, N,N-di-Me

Cas Number:

68308-74-7

Molecular formula:

not applicable for UVCB

IUPAC Name:

Amides, tall-oil fatty, N,N-di-Me

Constituent 2

Reference substance name:

DMATO

IUPAC Name:

DMATO

Test material form:

other: liquid

Details on test material:

DMAD Lot 418. = 90% DMATO

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

The animals were male adult rabbits, with body weights of 1184 to 1858 g. They were housed individually in screen-bottom cages, and supplied with water and commercial laboratory chow ad libitum.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Test sites were clipped before exposure. The test material was injected under a rubber sleeve, fastened around the trunk of the animal. The animals were immobilised during the 24 hour exposure period. The rubber sleeve was removed after 24 hours and the rabbits returned to their cages.

Duration of exposure:

24 hours

Doses:

2, 4 and 8 mL/kg bw

No. of animals per sex per dose:

2 male rabbits/dose

Control animals:

not required

Details on study design:

The rabbits were observed for 14 days. Body weights and mortality were reported.

Statistics:

Not performed.

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

8 mL/kg bw

Based on:

test mat.

Mortality:

1 rabbit exposed to 2 mL/kg bw and 1 rabbit exposed to 8 mL/kg bw died during week 1 of the observation period.

Clinical signs:

other: Not reported.

Gross pathology:

Not performed.

Other findings:

No other findings reported.

Any other information on results incl. tables

Table 1. Results.

Animal number	Dose (mL/kg bw)	Body weight (g) and mortality
		Initial	Week 1	Week 2
1	2	1560	died on test	-
2	2	1825	1823	2051
3	4	1518	1328	1662
4	4	1823	1288	1149
5	8	1858	1591	1735
6	8	1184	died on test	-

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was reported to be 8 mL/kg bw.

Executive summary:

The acute dermal toxicity of DMAD was evaluated in six male rabbits. The study was conducted prior to development of the guidelines and GLP, has several deficiencies, but is considered to be adequate for the purposes of hazard classification. The test material was injected under a rubber sleeve fastened around the animal. Dose levels were 2, 4 and 8 mL/kg bw (2 rabbits/dose). The rubber sleeve was held in place for 24 hours, and the rabbits were observed for 2 weeks following exposure. One rabbit exposed to 2 mL/kg bw and one rabbit exposed to 8 mL/kg bw died during week 1. All surviving rabbits lost weight during week 1, and one rabbit also lost weight during week 2. The LD50 was reported to be 8 mL/kg bw. Based on a relative density of 0.891, the dermal LD50 is 7128 mg/kg bw.