Adipic acid, compound with hexane-1,6-diamine (1:1)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Report date:

1978

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Report date:

2001

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Remarks:

This study was conducted prior to, but consistent with, US GLP guidelines published in 21 CFR 58:1978 and effective June 20, 1979.

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Adipic acid, compound with hexane-1,6-diamine (1:1)

EC Number:

222-037-3

EC Name:

Adipic acid, compound with hexane-1,6-diamine (1:1)

Cas Number:

3323-53-3

Molecular formula:

C6H16N2.C6H10O4

IUPAC Name:

hexanedioic acid - hexane-1,6-diamine (1:1)

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
2 males and 1 female New Zealand albino rabbits
Weight at study initiation: 2.3 kg (male no. 1); 2.3 kg (male no. 2); 1.9 kg (female)
No further data.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: the excess test substance was wiped off at 24 h after beginning of application

Duration of exposure:

24 h

Doses:

5010, 7940 mg/kg bw

No. of animals per sex per dose:

1 male (5010 mg/kg bw);
1 male and 1 female (7940 mg/kg bw)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: All rabbits were observed approximately 1 hour after dosing and twice daily over the 1 4-day observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 940 mg/kg bw

Remarks on result:

other: no mortality occurred

Mortality:

No deaths occurred throughout the 14-day treatment and observation period at either dose level tested.

Clinical signs:

other: Clinical signs observed included reduced appetite and activity, salivation and ocular discharge.

Gross pathology:

At necropsy, the viscera of all animals appeared normal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on key study data, AH-salt is not classified for dermal acute toxicity according to EU GHS classification and according to annex VI-Directive 67/548/EEC.

Executive summary:

Nylon Salt Solution (50% aqueous) was administered to the shaved, intact skin of New Zealand Albino rabbits under occlusive conditions for 24 hours. One animal was exposed to 5010 mg/kg and two rabbits were exposed to 7940 mg/kg. All rabbits were observed approximately 1 hour after dosing and twice daily over a 1 4-day observation period and given a gross necropsy. A Minimum Lethal Dose was estimated.

No deaths occurred throughout the 14-day treatment and observation period at either dose level tested. Clinical signs observed included reduced appetite and activity, salivation and ocular discharge. At necropsy, the viscera of all animals appeared normal. The dermal Minimum Lethal Dose was determined to be greater than 7,940 mg/kg in the rabbit.