Registration Dossier

Administrative data

Description of key information

One pre-OECD guideline and non-GLP in vivo skin irritation/corrosion study was conducted in rabbits. The skin of two animals were treated with 0.5 mL of undiluted isobutylamine during 1 hour under occlusive dressing.

Immediately after removal of the dressing, clear skin corrosive effects were noted on the application area.

No in vivo eye study was conducted due to the corrosive properties of the substance.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Two animals treated simultenaously
GLP compliance:
no
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

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

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.
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).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the above stated assessment of the skin irritation/corrosion potential, isobutylamine does have to be classified as Skin corrosive Category 1B (H314Causes severe skin burns and eye

damage) according to CLP (Regulation (EC) No 1272/2008 Of the European parliament and of the Council.