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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:
June 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

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:
solid: flakes
Details on test material:
- Name of test material (as cited in study report): Cosmacol ECL

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Padre Antonio - Mariano Comense, Italy
- Age at study initiation: no data
- Weight at study initiation: 2,5 - 3,5 kg
- Housing: stainless steel cages (4S0x500x380 mm) equipped with automatic washing cycle
- Diet: standard pellet complete diet supplied by the authorized breeder
- Water: filtered tap water from local network ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1992-06-01 To: 1992-06-08

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: sesame seed oil
Controls:
no
Amount / concentration applied:
500 mg test substance was turned to a paste with 0.5 mL of sesame seed oil
Duration of treatment / exposure:
4 h
Observation period:
24, 48 and 72 h after treatment
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 20 cm² of the right flank
- % coverage: no data
- Type of wrap if used: square gauze pad (2.5 x 2.5 cm) fixed to adhesive tape (Hansamed strips) , kept in plase by thin bands of adhesive hypoallergenic tape (Blenderm 3M), the entire trunk of the animal then wrapped with rubberized cloth (Acrylastic Beyersdorf AG , Hamburg)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, using a pad soaked in distilled water
- Time after start of exposure: 4 h

SCORING SYSTEM:
see Table #1 below

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0

Any other information on results incl. tables

Table #2: 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

0/0/0/0/0/0

0/0/0/0/0/0 

24 h

 0/0/0/0/0/0

 0/0/0/0/0/0

48 h

 0/0/0/0/0/0

 0/0/0/0/0/0

72 h

 0/0/0/0/0/0

 0/0/0/0/0/0

Average 24h, 48h, 72h

 0

 0

Reversibility*)

 -

Average time (unit) for reversion

 -

-

 

*) 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:
Under te conditions the test material 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tri-C14-15-alkyl esters can be considered non irritant.
Executive summary:

The test was performed by means of a single dose application of the test material 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tri-C14-15-alkyl esters on the skin of 6 albino male rabbits. The test material was applied to the shaved skin of 6 rabbits at a dose of 500 mg/rabbit for 4 hours, prepared as a paste with 0.5 ml of sesame seed oil. The animals were observed after the removal of the bandages and after 24, 48 and 72 hours for signs of erythema or oedema. During the study in all treated animals no erythema and edema were observed. Under test conditions the test material can be considered non irritant.