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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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).