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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:
1984-02-14 to 1984-02-23
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report which meets basic scientific principles and was performed according to internationally accepted testing guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Vestinol TD
- Substance type: pure active substance
- Physical state: liquid
- Lot/batch No.: T 53/124312173
- Other: Date of production: 1983-09-01

Test animals

Species:
rabbit
Strain:
other: Small White Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.4 - 2.6 kg
- Housing: single housing in stainless steel cages
- Diet: Ssniff K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water: Drinking water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm³
Duration of treatment / exposure:
4 hours
Observation period:
up to 9 days
Number of animals:
6 (3 male, 3 female)
Details on study design:
TEST SITE
- Area of exposure: 6 cm² of shaved skin of the dorsal and lateral parts of the trunk of the animals
- % coverage: not mentioned
- Type of wrap if used: on the application area a linen patch (2,5 x 2,5 cm) was placed, which was covered with a
polyethylene film (6 x 6 cm). The application area was then immobilised with an elastic dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.34
Max. score:
8
Reversibility:
fully reversible within: 9 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Average 24, 48 and 72 hours
Score:
0.17
Reversibility:
fully reversible within: 9 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Average 24, 48 and 72 hours
Score:
0.17
Reversibility:
fully reversible within: 6 days
Irritant / corrosive response data:
AVERAGE SCORE (24, 48, and 72 hours)
- Erythema: 0.17
- Edema: 0.17
Other effects:
One animal showed two reddish, swollen spots of approx. 1 cm diameter on day 6, which formed small crusts later on. On
Day 8 the crusts detached.

Any other information on results incl. tables

Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test.

Score at time point / Reversibility

Erythema Max. score:

Edema Max. score:

60 min

0/0/0/0/0/0

0/0/0/0/0/0

24 h

0/1/0/0/0/0

0/0/0/0/0/0

48 h

0/1/0/0/0/0

0/1/0/0/0/0

72 h

0/1/0/0/0/0

0/1/0/0/0/0

Average 24h, 48h, 72h

0.17

0.17

Reversibility *)

c.

c.

Average time (unit) for reversion

9 days

6 days

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Executive summary:

In this study, rabbits were exposed to DTDP at doses of 0.5 cm³ for 4 hours via a linen patch covered with a polyethylene film. Dermal assessment occurred daily for up to 9 days post exposure. Every animal survived exposure. One animal exhibited erythema at 24 hours and one animal exhibited edema at 48 hours, but all animals were free of any dermal irritation by day 9.