Isopentylamine

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same 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:

other: OECD TG 402

Deviations:

no

GLP compliance:

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

Radiolabelling:

no

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

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per group:

5/sex

Control animals:

no

Remarks:

not required

Details on study design:

Deatils on dermal expsoure:
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 observation period following administration: 14 days
- Frequency of observations and weighing: 0, 7, and 14 d (bw)
- Necropsy of survivors performed: yes

Results and discussion

Signs and symptoms of toxicity:

no effects

Remarks:

no systemic effects noted

Dermal irritation:

yes

Remarks:

severe corrosion in all animals. 5 animals killed for humane reasons on days 7-10

Applicant's summary and conclusion

Conclusions:

Isopentylamine caused skin corrosion. It may have been systemically available, but no signs of systemic toxicity were noted at a dermal dose as high as 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. Isopentylamine may have been systemically available, but no signs of systemic toxicity were noted (Safepharm, 1985).