Registration Dossier

Diss Factsheets

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:
1989-04-18 to 1989-05-26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

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

Test material

Constituent 1
Reference substance name:
former CAS No. 67989-23-5
IUPAC Name:
former CAS No. 67989-23-5
Constituent 2
Reference substance name:
1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters
EC Number:
290-754-9
EC Name:
1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters
Cas Number:
90218-76-1
IUPAC Name:
90218-76-1
Details on test material:
- Name of test material (as cited in study report): Witamol 218
- Substance type: product
- Physical state: liquid
- Stability under test conditions: not mentioned
- Storage condition of test material: not mentioned
- Other: none

Test animals

Species:
rabbit
Strain:
other: Small White Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.1 - 2.3 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): 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 mL
Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 10 x 10 cm of shaved skin of the dorsal and lateral parts of the trunk of the animals, application of the test substance on a skin area of approx. 6 cm²
- % coverage: not mentioned
- Type of wrap if used: semi-occlusion with a gauze patch (2.5 cm x 2.5 cm). The patch was secured in position by an elastic bandage.

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:
1.67
Max. score:
8
Reversibility:
fully reversible within: 6 to 8 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal: #1 and #2
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable as no effect has been observed
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 1.56
- Edema: 0.11
All animals showed slight to well-defined erythema, and two animals after 1 resp. 24 hours slight edema. Allanimals were free of symptoms after 6 - 8 days.
Other effects:
scurf formation in one animal

Any other information on results incl. tables

Table #: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

60 min

1/2/1

 0/1/0

24 h

 1/2/2

 0/0/1

48 h

 1/2/2

 0/0/0

72 h

 1/2/1

 0/0/0

Average 24h, 48h, 72h

 1.56

 0.11

Reversibility*)

 c.

 c.

Average time (unit) for reversion

 8 days

 8 days

 

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

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this OECD guideline study 404, all rabbits exposed to undiluted 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters for 4 hours under semiocclusive conditions showed slight to well-defined erythema (scores 1 to 2), and two animals after 1 resp. 24 hours slight edema (score 1). Mean erythema scores from 24, 48 and 72 hour readings for each animal were in between 1 and 2. In two animals mean edema score was 0 and in one animal the mean edema score was 0.3. All animals were free of symptoms after 6 - 8 days. The test material thus showed only very weak irritating effects on the skin of trabbits.
Executive summary:

To test the acute skin irritant effect, 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was applied to shaven dorsal skin of rabbits. The product was administered undiluted, and the time of exposure in the patch test was 4 hours. The test was carried out in accordance with OECD guideline 404 (12 May 1981).

The test substance showed only a slightly irritating effect (primary dermal irritation index (PDII): 1.67) on the skin of male rabbits. Mean erythema scores from 24, 48 and 72 hour readings for each animal were in between 1 and 2. In two animals mean edema score was 0 and in one animal the mean edema score was 0.3. All animals were free of symptoms after 6 - 8 days.