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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:
11 - 25 Oct. 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Di-i-propylamin
- Molecular formula (if other than submission substance): C6H15N
- Molecular weight (if other than submission substance): 101.2
- Substance type: organic
- Physical state: liquid
- Analytical purity: 99%
- Purity test date: no data
- Lot/batch No.: RM 132465
- Storage condition of test material: in the dark at 2°C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: in house
- Age at study initiation: no data
- Weight at study initiation: 3.4 - 4.0 kg
- Housing: single, air-conditioned
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-2
- Humidity (%): 55 +-10
- Photoperiod (hrs dark / hrs light): 12 / 12


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:
3 min
Observation period:
30 - 60 min, 24, 48, 72 h, 7, and 14 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5cm x 2.5 cm
- Type of wrap if used: adhesive patch + tissue bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 3 min

SCORING SYSTEM: Draize numerical scoring system.
Calculation of an average score over time (24, 48, and 72 h) and animals from individual effects values of erythema and edema separately as well as combined.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24-48-72h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14d
Remarks on result:
other: necrosis
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean 24-48-72h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14d
Remarks on result:
other: necrosis
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24-48-72h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14d
Remarks on result:
other: necrosis
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean 24-48-72h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean 24-48-72h
Score:
0.67
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean 24-48-72h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritant / corrosive response data:
Clear evidence of necrosis:
Brown-red and brown-green discoloration of treated skin sites within 24 h, followed by dry and rough over time, associated with desquamation and/or open wound that ended in scar formation. The skin tissue became irreversibly damaged in total thickness.

Any other information on results incl. tables

Time 0,5 - 1h 24h 48h 72h 7d 14d
Animal 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3
Erythema 3 3 3 2 3 3 2 3 3 2 3 3 2 3 3  *  *  *
Oedema 1 1 1 1 1 1 1 1 1 1 0 1 2 2 1  *  *  *

Applicant's summary and conclusion

Interpretation of results:
Category 1A (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
Conclusions:
DIPA is considered as corrosive to rabbit skin.
Executive summary:

The acute dermal irritation of Diisopropylamine (DIPA) was evaluated in rabbits according to OECD 404 guideline and in compliance with the Good Laboratory Principles. DIPA was applied undiluted to the skin of 3 New-Zealand White albino rabbits and held in contact for 3 minutes by means of a semi-occlusive dressing. Animals were then observed daily until day 14.

Clear evidence of necrosis was observed within 24 h (brown-red and brown-green discoloration of treated skin sites), followed by dry and rough over time, associated with desquamation and/or open wound that ended in scar formation. The skin tissue became irreversibly damaged in total thickness.

Erythema mean scores over 24, 48 and 72 hours were 2, 3 and 3 for animals 1, 2 and 3 respectively.

Oedema mean scores over 24, 48 and 72 hours were 1, 0.67 and 1 for animals 1, 2 and 3 respectively. Skin damages were not reversible within the observation period.

Under these experimental conditions, DIPA is considered as corrosive to rabbit skin.