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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:
1990-10-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to OECD 404 guideline and in compliance with the GLP Regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 6398-21-1
- Physical state: clear, colorless liquid
- Analytical purity: responsibility of the Sponsor
- Stability under test conditions: no apparent change in the physical state of the test article during administration
- Other: total amount submitted :1408.3g (materials and containers)/pH=10 (litmus paper)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hare-Marland, Hewitt, NJ
- Age at study initiation: adult
- Weight at study initiation: 2.504-2.865 kg
- Housing:Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the
Institute of Laboratory Animal Resources, National Research Council.
- Diet (e.g. ad libitum): Purina Rabbit Ration HF, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum.
- Acclimation period: min.5d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C±3°C (63-73°F)
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light):12h light, 12h dark


IN-LIFE DATES: From: To:

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: OECD 404: untreated area of the test animal serves as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL/site
Duration of treatment / exposure:
4h (upper: intact dorsal trunk)
24h (lower: intact and abraded dorsal trunk)
Observation period:
14d
Number of animals:
6 (3M and 3F)
Details on study design:
TEST SITE
- Area of exposure: dorsal trunk (clipped free of fur)
- Type of wrap if used: rubber dam and an elastic bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: 4 and 24h


SCORING SYSTEM: observation
Draize Evaluation of Dermal Irritation (Primary Irritation Index) and Modified Primary Irritation Index

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
8
Remarks on result:
other: 8=severe dermal irritation
Irritation parameter:
erythema score
Basis:
animal: 6/6
Time point:
other: 30min (4h exposure)
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
14d observation
Remarks on result:
other: severe erythema, sloughing, fissuring and necrosis
Irritation parameter:
edema score
Basis:
animal: 6/6
Time point:
other: 30min (4h exposure)
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
14d observation
Remarks on result:
other: severe edema, sloughing, fissuring and necrosis
Irritation parameter:
erythema score
Basis:
animal: 6/6
Time point:
other: 24h (24h exposure)
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
14d observation
Remarks on result:
other: severe erythema, necrosis, sloughing and fissuring
Irritation parameter:
edema score
Basis:
animal: 6/6
Time point:
other: 24h (24h exposure)
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
14d observation
Remarks on result:
other: severe edema, sloughing and fissuring
Irritant / corrosive response data:
irreversible severe erythema (including necrosis, sloughing, fissuring) and severe edema is observed 30 min after 4h exposure. The skin damage remained throughout the study (14d)

Applicant's summary and conclusion

Conclusions:
The test article was considered to be a severe dermal irritant at both 4 and 24 hour exposures.