Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22.04.1992 to 15.05.1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
other: White russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: ASTA Medica AG, D-4802 Halle-Künsebeck
- Age at study initiation: Nine months
- Weight at study initiation: Males: 2.49 and 2.52 kg; Female: 2.76 kg
- Housing: Individually in stainless steel cages
- Diet: 120 g/day/animal
- Water: Ad libitum
- Acclimation period: At least one day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 42-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 27.04.1992 To: 15.05.1992

Test system

Type of coverage:
occlusive
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:
Four hours
Observation period:
9/10 days after application (at 1, 24, 48 and 72 hours, then daily)
Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: Dorsal area between shoulder and sacrum
- % coverage: No data, but was 6.25 cm2
- Type of wrap if used: Occlusive (patch made of the following layers: cellulose gauze, cellulose fabric coated with natural rubber, synthetic film glue; a bandage was then wrapped several times around the trunk to provide complete occlusion).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: Four hours

SCORING SYSTEM: Gilman et al (1983) Relationship between the primary dermal irritation index and ocular irritation. J. Toxicol.-Cut. & Ocular Toxicol. 2, 107-117.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
5.1
Max. score:
8
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Mean scores for erythema for 24, 48 and 72 hours were at least 2.3 in all animals. The mean scores for edema for 24, 48 and 72 hours were at least 2.3 in 2/3 animals.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 9 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 9 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 9 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Table 1. Severe changes were noted in the animals. Erythema occurred in all three animals. In 2/3 animals there was moderate to severe (grade 3) erythema at one hour. At this time the erythema in the third animal was well-defined (grade 2), then at 24 hours it was moderate to severe (grade 3). These findings had completely disappeared by day 10 of the observation period. In addition, skin scales, which immediately peeled off, were observed in all three animals from day 7 onwards.

A moderate oedema (grade 3) was noted in two animals after one hour of patch removal. The edema was severe in the third animal (grade 4). These findings had reversed by day 10.
Other effects:
Systemic effects did not occur in any animals.

Any other information on results incl. tables

Table 1 Summary of skin irritation scores

  Skin reaction    Hours/days after exposure  Animal 1 scores Animal 2  scores Animal 3 scores
Erythema and eschar  1 hr   2  3  3
  24 hr   3  3  3
  48 hr   3  2  2
  72 hr   3  2  2
  4 d   3  2  2
  7 d   2  2  3
  9 d   1  0  1
  10 d   0    0
Edema   1 hr   3  3  4
  24 hr   3  3  3
  48 hr   2  2  2
  72 hr   2  2  1
  4 d   2  2  1
  7 d   1  2  2
  9 d   0  0  1
  10 d   0    0

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
In an occlusive skin irritation study conducted according to OECD 404 and in compliance with GLP (reliability score 1) triethoxyoctylsilane was irritating to the skin of rabbits. Irritation had completely reversed by day 10. There were no systemic effects.