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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Exposure time
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropylamine
EC Number:
200-860-9
EC Name:
Isopropylamine
Cas Number:
75-31-0
Molecular formula:
C3H9N
IUPAC Name:
propan-2-amine
Test material form:
liquid
Details on test material:
Isopropylamine [CAS No. 75-31-0]; supplied by Hoechst Celanese Corp. (C-899; not further specified)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Mohican Valley Rabbitry, Loudonville, Ohio, USA
- Age at study initiation: young adults
- Weight at study initiation: 1.9 - 2.2 kg
- Housing: individually housed in stainless steel cages
- Diet, water: ad libitum

- Acclimation period: > 5d


ENVIRONMENTAL CONDITIONS
- Temperature: 65 - 78°F
- relative Humidity: 35-70%
- Air changes (per hr): no information given
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
amount (volume): 0.5 ml
Duration of treatment / exposure:
3 min (and 1 h, not further considered)
Observation period:
3 min, 1, 24, 48 and 72h and 7 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: right flank
- Type of wrap : 1.5 in x1.5 in (= 3.81 cm x 3.81 cm) gauze patch wrapped with a double layer plastic wrap


REMOVAL OF TEST SUBSTANCE
- Washing: wiped with gauze soaked with distilled water
- Time after start of exposure: 3 min


SCORING SYSTEM for erythema and edema respectively from 0 (no effect) to 4 (severe effect) according to Draize (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Remarks on result:
other:
Remarks:
mean value of three timepoints
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Remarks on result:
other:
Remarks:
mean value of three timepoints
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Remarks on result:
other:
Remarks:
mean value of three timepoints
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7d
Remarks on result:
other: Necrosis (after 3 min), eschar formation (after 24 h)
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 d
Remarks on result:
other: Necrosis (after 3 min), eschar formation (after 24 h)
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 d
Remarks on result:
other: Necrosis (after 3 min), eschar formation (after 24 h)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 3 min
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: necrotic centre, scored at edge of test site
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 3 min
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: scored within and around test site
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 3 min
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks:
7 d
Remarks on result:
other: scored within and around test site
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: scored at edge of test site
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: scored at edge of test site
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: scored at edge of test site
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within:
Remarks:
7 days
Remarks on result:
other:
Remarks:
mean value of three timepoints
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within:
Remarks:
7 days
Remarks on result:
other:
Remarks:
mean value of three timepoints
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within:
Remarks:
7 days
Remarks on result:
other:
Remarks:
mean value of three timepoints
Irritant / corrosive response data:
The treatment produced immediate necrosis and subsequently eschar within 24 h.
The scores mentioned above relate to symptoms around the necrotic centre.

Applicant's summary and conclusion

Interpretation of results:
Category 1A (corrosive)
Conclusions:
Under the conditions of this study, the test substance was corrosive to the skin of rabbits
Executive summary:

The potential irritant and corrosive properties of the test substance were evaluated on New Zealand White rabbits.0.5 mL of undiluted test substance was applied to the skin of three animals, held in place with a gauze patch and covered for 3 minutes. The test substance was wiped off thereafter and the application sites immediately graded for dermal reactions. Necrosis was produced by this treatment, progressing to eschars at 24 h post exposure, which did not recover within 7 days. There were also slight edema, which were fully reversible within the observation period.