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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
August4-19,1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to OECD 404 guideline and GLP regulations, there were no deviations from these regulations. No data on purity were indicated.

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)
Deviations:
yes
Remarks:
stability/purity not reported
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 6933-6-20
- Physical state: clear, yellow liquid
- Analytical purity: no data
- Stability under test conditions: no apparent change in the physical state of the test article
- Amount received: 662.77 g (gross weight)
- pH: 8 (litmus paper)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazelton Research Products, Denver, PA
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 2.325-2.607kg
- Housing:Rabbits were housed individually in cages sized in accordance with the ''Guide for the Care and Use of Labolatory Animals'' of the Institute of National Research Council.
- Diet (e.g. ad libitum): Purina Lab Rabbit Chow (H.F.) ad libitum
- Water (e.g. ad libitum):fresh tap water, ad libitum
- Acclimation period: minimum 5d


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


Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL/site (6 cm²)
Duration of treatment / exposure:
The test article was administrated once per site:
-3 min, 60 min, 4h, 24 h
Observation period:
14d
Number of animals:
Six (6) :3♂ and 3♀
Details on study design:
TEST SITE
- Area of exposure: 5 sites on the dorsal trunk
- % coverage:
- Type of wrap if used: impervious material

REMOVAL OF TEST SUBSTANCE
- Washing (if done): by using water and a gauze
- Time after start of exposure: 3 min, 60min, 4h, 24h


SCORING SYSTEM:
Draize Evaluation of Dermal Irritation, Primary Irritation Index

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 4h exposure
Score:
8
Remarks on result:
other: severe dermal irritation at 4 and 24h exposure
Irritation parameter:
erythema score
Basis:
animal: 6 animals
Time point:
other: 3min
Score:
>= 0 - <= 2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: 6 animals
Time point:
other: 3 min
Score:
>= 0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: 5/6 animals
Time point:
other: 24h - 14 days
Score:
>= 4
Max. score:
4
Remarks on result:
other: necrosis
Irritation parameter:
edema score
Basis:
animal: 5/6 animals
Time point:
other: 24h - 14 days
Score:
>= 4
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24h
Score:
>= 1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24h
Score:
>= 1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 48h
Score:
>= 2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 48h
Score:
>= 0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 72h
Score:
>= 4
Max. score:
4
Remarks on result:
other: necrosis
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 72h
Score:
>= 4
Max. score:
4
Irritant / corrosive response data:
results in above table are observed after 3 min exposure (except PDII).
animals have been exposed for 60min, 4h, and 24h. All animals scored 4 (necrosis) for erythema and edema immediately after unwrapping.
Severe erythema and severe edema remained present in all animals at all observation periods during the study (up to 14 days).


Any other information on results incl. tables

 

 Animal No.  Sex  Body Weight Initial (kg)  Body weight Final (kg)
 1  M 2.405   2.752
 2  M  2.514  2.707
 3  M  2.387  2.673
 4  F  2.591  2.847
 6  F  2.607  2.903
 6  F  2.325  2.495

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test article was considered to be severe dermal irritant at both 4 and 24 hour exposures.
The Dermal Irritation Toxicity Category is Class I (corrosive).
The DOT Packing Group Classification is Class I (corrosive at less than 3 min).
Primary Dermal Irritation Index at 4h and 24h exposure=8.00 (according to Draize scoring system).
Executive summary:

TETA was examined undiluted for skin irritation in groups of 3 rabbits per sex. The test material was applied (occlusive) directly on the intact and abraded skin sites. The skin was abraded using a burred needle, the abrasion penetrated the stratum corneum, but not the derma. The test article was administrated once per site for 3 min, 60 min, 4h, or 24 h. Necrosis was observed after 3 min exposure. The animals that had been exposed for 60 min, 4 h, or 24h scored 4 (necrosis) for erythema and edema immediately after unwrapping. Severe erythema and severe edema remained present in all animals at all observation periods during the study (up to 14 days).