Isopentylamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 July - 19 Aug. 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according 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:

Isopentylamine

EC Number:

203-526-0

EC Name:

Isopentylamine

Cas Number:

107-85-7

Molecular formula:

C5H13N

IUPAC Name:

isopentylamine

Details on test material:

Isoamylamine [CAS No. 107-85-7], not further specified

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: A. Tucks & Sons Ltd., Battlesbridge/Essex
- Age at study initiation: 10 - 12 wks
- Weight at study initiation: 228 - 239 g (m); 200 - 203 g (f)
- Fasting period before study: no
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >=5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3°C
- Humidity (%): 60 - 70
- Air changes (per hr): ~10/h
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 7 x 4 cm patch
- % coverage: ~10 % of total body surface
- Type of wrap if used: patch of surgical lint


REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/ml
- Concentration (if solution): 50 % (w/v)
- Constant volume or concentration used: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml water/ml

Duration of exposure:

24 h

Doses:

2000 mg/kg bw (limit test)

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0, 7, and 14 d (bw)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

other: 5 animals killed for humane reasons on days 7-10

Mortality:

none, 5 animals killed prior to termination for humane reasons

Clinical signs:

no particular findings

Body weight:

increase normal, but slight loss in one female

Gross pathology:

congestion of the lung, corrosive effects at the treated skin site associated with eschar formation, loss of suppleness or necrosis, and local subcutaneous hemorrhage in rats that were kileld for humane reasons

Any other information on results incl. tables

In the preliminary study, skin corrosion was seen in all animals treated with the neat substance.

Therefore, a 50% solution of the amine in water was used in the definitive study, which, however, resulted also in skin corrosion.

5 animals were killed for humane reasons (one male on day 10; four females on days 7-10). No evidence of systemic toxicity was previously noted. The body weight of surviving rats was not affected.

 

Applicant's summary and conclusion

Conclusions:

3-methylbutylamine (2000 mg/kg bw, 50% in water) caused severe skin corrosion in rats. % of 10 rats were killed for humane reasons on days 7-10. The LD50 was therefore 2000 mg/kg bw.

Executive summary:

The acute dermal toxicity was tested according to the OECD TG 402 and under GLP conditions. 5 male and female Sprague-Dawley rats received 2000 mg/kg bw of 3-methylbutylamine (50% in water), and the animals were observed until the end of the 14-day observation period. No systemic toxicity was seen in any rat. However, 5 of 10 animals were killed for humane reasons (one male on day 10; four females on days 7-10), based on the poor state of the skin. In the preliminary study, skin corrosion had been seen in all animals treated with the neat substance at 2000 mg/kg bw. In an attempt to reduce the local effects, a 50% solution of the amine in water was used in the definitive study, which, however, resulted also in skin corrosion.

 

Based on the above, the acute dermal LD50 value is 2000 mg/kg bw in the rat (Safepharm, 1985).