Isobutylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Pre-OECD guideline study and Non GLP study. Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Two animals treated simultenaously

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isobutylamine

EC Number:

201-145-4

EC Name:

Isobutylamine

Cas Number:

78-81-9

Molecular formula:

C4H11N

IUPAC Name:

2-methylpropan-1-amine

Details on test material:

- Name of test material (as cited in study report): isobutylamine
- Physical state: clear liquid
- Analytical purity: not stated

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: not stated
- Weight at study initiation: 1.5 to 2.0 kg
- Housing: singly
- Diet: standard diet ERKA 8300 ad libitum
- Water: tap water ad libitum
- Acclimation period: not applicable


ENVIRONMENTAL CONDITIONS
no details reported

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

1 hour

Observation period:

1 hour

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: two areas, each 2.5 cm x 2.5 cm.
- Skin: intact and scarified
- Type of wrap if used: cotton gauze, covered by a PVC film, held in place by an elastic bandage.


REMOVAL OF TEST SUBSTANCE
- Washing: not stated
- removal of test patch: 1 hour after start of exposure

EVALUATION
- Time after start of exposure: 1 hour

SCORING SYSTEM: not defined

Results and discussion

In vivo

Results

Irritation parameter:

other: not evalutated due to obvious corrosion

Basis:

other: see above

Time point:

other: 1 hour post application

Reversibility:

not reversible

Remarks on result:

other: Deep skin corrosion; evalution of irritation parameters not needed

Irritant / corrosive response data:

Inspection of the intact skin test site after the 1-hour expsoure period revealed superficial chaps and colorless exsudation; pigmentation (green-brown-black) of the corroded skin; deep skin corrosion.

,, dark red erythema and deep skin corrosion was noted.

Other effects:

Animals were excited 20 min past application and inactive thereafter.

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Remarks:

Migrated information R 34 Criteria used for interpretation of results: other: EU, 67/548 EEC; Annex VI

Conclusions:

Isobutylamine caused full thickness corrosion of the the rabbit's skin within a 1-hour exposure period.

Executive summary:

Isobutylamine caused full thickness corrosion of the rabbit's skin within a 1-hour exposure period in a valid non-GLP study conducted similar to OECD TG 404 (two Albino Himalayan rabbits tested; 0.5 mL undiluted test substance applied to intact skin) (Hoechst, 1979).