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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:
From 27 October 1987 to 23 December 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Non GLP compliant study, method according to OECD TG 404. Sufficient information but no more details on the method in the report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
No details on the test method but sufficient for assessment. No certificate of analysis provided.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: not specified
- Expiration date of the lot/batch: not provided in the present report
- Purity test date: not provided in the present report

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
- Stability under test conditions: not applicable
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Age at study initiation: not specified
- Weight at study initiation: 2.83 kg for male and 2.58 kg for female
- Housing:cage made of stainless steel with wire mesh walk floors (40x51cm for floor area)
- Diet (e.g. ad libitum): Kliba 341.4 mm about 130g per animal per day
- Water (e.g. ad libitum): 250 mL tap water per day per animal
- Acclimation period: at least 8 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-% relative humidity
- Air changes (per hr): fully air-conditioned room
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours (6:00 to 18:00 light period)

IN-LIFE DATES: From: Not specified : To : 11 November 1987

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): pure

VEHICLE
Not applicable
Duration of treatment / exposure:
4 hours
Observation period:
30-60 minutes after removal and 24 hours, 48 hours, 72 hours, 8 days and 15 days after the beginning of the treatment
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Upper third of the back or flanks
- % coverage: not specified
- Type of wrap if used: test patches were secured in position with a porous dressing (four layers of absorbent gauze and porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lutrol and lutrol/water
- Time after start of exposure: at the end of the exposure period (after 4 hours)

OBSERVATION TIME POINTS
(indicate if minutes, hours or days)

SCORING SYSTEM:
- Method of calculation: calculation of the mean according to 83/467/EEC criteria of july 29th 1983

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.5
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
14 d
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
14 d
Score:
1
Max. score:
1
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
14 d
Score:
1
Max. score:
1
Reversibility:
not reversible

Any other information on results incl. tables

Table 1 :Results

Readings

Animal

Erythema

Edema

Symptoms

4hours

1

2

2

R:E / ED:E

 

2

2

2

R:E / ED:E

 

3

2

2

R:E / ED:E

24hours

1

2

3

R:E / ED:E

 

2

2

2

R:E / ED:E

 

3

2

3

R:E / ED:E

48hours

1

2

2

R:E / ED:E

 

2

2

1

R:E / ED:E

 

3

2

2

R:E / ED:E

72hours

1

2

1

R:E / ED:E

 

2

2

0

R:E

 

3

2

1

R:E / ED:E

8days

1

4

2

R:E / ED:E

 

2

1

0

R:E/ S:SE, E

 

3

1

1

R:E/ED:E/S02

15days

1

2

1

RE:E / ED:E

 

2

0

0

S:SE:E

 

3

0

1

S02/ED:E

Mean

1

2

2

 

2

2

1

 

3

2

2

Mean

1, 2 and 3

2

1.7

 

Evaluation of erythema (R) and edema (ED)

0 : None

1: Very slight

2: Well defined

3: Moderate to severe

4: Severe to very severe

Explanation of symptoms:

S02: Superficial scurf

ED:E:Edemea, Extending beyond the area of exposure

R:E: Erythema, Extending beyond the area of exposure

S:E,E : Scaling, severe, Extending beyond the area of exposure

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Based on the results of this study, the trihexylamine induced irritation when applied on clipped skin. This adverse effect was not completely reversible up to 15 days of exposure. According to CLP regulation, the test item trihexylamine was classified as Irritant Category 2.
Executive summary:

This non-GLP compliant study was performed to evaluate the skin irritation potentiel of the test item tri-N-hexylamine. This study follows the OECD TG 404 method.

Vienna White rabbits were used in this study. They were dermally treated with 0.5 mL of unchanged test item in clipped skin under semi-occlusive condition for 4 hours. Readings for erythema and edema score were performed 30 to 60 minutes after patch removal, 24, 48, 72 hours after the beginning and 8 and 15 days after the beginning of the treatment.

The test item induced irritation (erythema and edema) to rabbit skin when applied. This irritation was not completely reversible until the day 15 of observation.

Based on the results of this study, the trihexylamine induced irritation when applied on clipped skin. This adverse effect was not completely reversible up to 15 days of exposure. According to CLP regulation, the test item trihexylamine was classified as Irritant Category 2.