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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (occlusive treatment)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(limited documentation, occlusive treatment)
Principles of method if other than guideline:
Method: BASF-Test
Three animals were treated for 3 min and 1 h using occlusive conditions. The application site of 2.5 x 2.5 cm (flanks) was covered with the liquid test substance. After exposure the skin was washed with Lutrol (conc.) and Lutrol/water (1:1). The animals were observed for 8 days and skin changes were recorded after patch removal, 24 h, 48 h and 8 days after application. The test is comparable to the initial test descirbed in the OECD guideline 404 to evaluate the corrosive potential of a test substance.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tetramethylpropandiamin-1,3
- Analytical purity: 99%
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Firma Gaukler; Offenbach Germany
- Weight at study initiation: 3.07 kg (mean)
- Housing: one per cage
- Diet: Ovator Solikanin 4 mm; Muskator-Werke Duesseldorf; ad libitum
- Water: FulIy demineralized water ad libitum each workday; tap water ad libitum on public holidays.
- Acclimation period: ca. 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 mL
Duration of treatment / exposure:
3 min (right flank) and 1 h (left flank)
Observation period:
8 days
Number of animals:
1 male and 2 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol (conc.) and Lutrol/water (1:1)
- Time after start of exposure: 3 min or 1 h

EVALUATION: according to the Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: corrosion
Basis:
mean
Remarks:
(3 animals, 3 min exposure)
Remarks on result:
other: Non-reversible necroses (superficial) were observed in all animals.
Irritation parameter:
other: corrosion
Basis:
mean
Remarks:
(3 animals, 1 h exposure)
Remarks on result:
other: Non-reversible, full thickness necroses were observed in all animals.
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(3 min exposure)
Time point:
other: 24 h - 48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(3 min exposure)
Time point:
other: 24 h - 48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(3 min exposure)
Time point:
other: 24 h - 48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(1 h exposure)
Time point:
other: 24 h - 48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(1 h exposure)
Time point:
other: 24 h - 48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(1 h exposure)
Time point:
other: 24 h - 48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(3 min exposure)
Time point:
other: 24 h - 48 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(3 min exposure)
Time point:
other: 24 h - 48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(3 min exposure)
Time point:
other: 24 h - 48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(1 h exposure)
Time point:
other: 24 h - 48 h
Score:
3.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(1 h exposure)
Time point:
other: 24 h - 48 h
Score:
3.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(1 h exposure)
Time point:
other: 24 h - 48 h
Score:
3.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU