Amines, N-C12–14 (even numbered)-alkyltrimethylenedi-, reaction products with chloroacetic acid and diethylenetriamine, N-C12–14 (even numbered)-alkyl derivs.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EPA 40 CFR, Par. 158.50 & 158.135, Subdivision F, Section 81-2, pp. 39 - 44, Nov. 1982

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-{[3-(dodecylamino)propyl]amino}acetic acid; {2-[(2-aminoethyl)amino]ethyl}(dodecyl)amine

IUPAC Name:

2-{[3-(dodecylamino)propyl]amino}acetic acid; {2-[(2-aminoethyl)amino]ethyl}(dodecyl)amine

Test material form:

solid - liquid: aqueous solution

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: at least 2-3 kg
- Diet (e.g. ad libitum): rabbit diet, ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature: 65-75°F
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorso-laterally from.the pectoral to the pelvic areas

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/ kg bw

Duration of exposure:

24 h

Doses:

2 g/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily (clinical signs), once a week (weighing), after 24 and 72 h (irritation)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, skin irritation:

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 450 mg/kg bw

Based on:

act. ingr.

Mortality:

2 females died.

Clinical signs:

other: depression, diarrhea, laboured breathing

Other findings:

The test item was corrosive.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Dermal LD50 Combined > 2000 mg test material/kg bw
Dermal LD50 Combined > 450 mg a.i./kg bw

Executive summary:

In an acute dermal toxicity study according to EPA 40 CFR, Par. 158.50 & 158.135, Subdivision F, Section 81-2, New Zealand White rabbits (5/sex) were dermally exposed to Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (22.5% a.i) for 24 hours at a single dose of 2000 mg/kg bw in terms of test material (corresponding to 450 mg a.i./kg bw). Animals then were observed for 14 days.

2/5 females died during the observation period. 5/8 surviving animals showed weight loss on day 14.

The test item was corrosive to the skin (edema and erythema scores of 4 after 24 and 48 h). The skin sites were severely burned and discoloured black. The skin was thickened and stiff.

 

Dermal LD50 Combined > 2000 mg test material/kg bw

Dermal LD50 Combined > 450 mg a.i./kg bw