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:
From 1986-02-11 to 1986-02-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.2-3.4 kg
- Housing: individually
- Diet: ad libitum
- Water : ad libitum
- Acclimation period: 1 week prior to the start of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 50±20%
- Photoperiod : 12 hrs dark / 12 hrs light


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
other: each animal served as its own control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied : 0.5 g
- Concentration (if solution):

VEHICLE
- Amount(s) applied : 0.9ml isotonic saline.
0.5 g test substance pasted with 0.9 ml isotonic saline.



Duration of treatment / exposure:
4 hours
Observation period:
30 min, 60 min, 24, 48, 72 hrs and 7d, 14d after removal the patch
Number of animals:
3 rabbits
Details on study design:
TEST SITE
- Area of exposure: skin of the back
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was removed from skin with warm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD guideline 404 (draize scoring system)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean of the 24, 48 and 72-hour readings
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean of the 24, 48 and 72-hour readings
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean of the 24, 48 and 72-hour readings
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean of the 24, 48 and 72-hour readings
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean of the 24, 48 and 72-hour readings
Score:
0
Max. score:
4
Irritant / corrosive response data:
For raw data see table 1 in the "remarks on results" freetext.
30-60 minutes and 24 hours after patch removal the animals showed very slight to well defined erythema. 48 hours to 7 days after patch removal two rabbits showed a very slight or well defined erythema. 14 days after application erythema and oedema formation were reversed. Additionally, the treated skin areas were sporadically dry-rough, discoloured light brown and fine or coarse scaly during the observation period.

Any other information on results incl. tables

Table 1 Individual skin irritation scores according to the OECD 404 guideline

Time after patch removal

30-60 minutes

24 h

48 h

72 h

7 d

14 d

Animal no.

1

2

3

1

2

3

1

2

3

1

2

3

1

2

3

1

2

3

erythema

2

1

1

2

1

1

2

1

0

2

1

0

2

1

0

0

0

0

oedema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

skin surface

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

- dry rough

 

 

 

 

 

x

x

 

x

x

x

x

x

x

x

x

x

 

- fine scaly

 

 

 

 

 

x

 

 

 

 

 

 

 

x

 

 

x

 

- coarse scaly

 

 

 

 

 

 

 

 

 

 

 

 

x

 

 

x

 

 

- large disol. light brown

 

 

 

 

 

 

 

 

 

x

 

 

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP (Reg. 1272/2008/EC) and Directive 67/548/EEC
Conclusions:
Under the experimental conditions of this study and according to the criteria laid down in CLP (Reg 1272/2008/EC) and directive 67/548/EEC, the test item dimethyldioctadecylammonium chloride (purity 97%) is not classified.
Executive summary:

The potential of Dimethyldioctadecylammonium chloride (purity 97%) to induce skin irritation was assessed in 3 rabbits according to the OECD guideline 404 and to the EU Method B.4. The study was conducted in compliance with the principles of Good Laboratory Practice regulations.

A single dose of 0.5 g pasted with 0.9 ml isotonic saline was applied to the skin of the rabbits under a semi-occlusive dressing for a 4-hour exposure period. Skin reactions were observed approximately 0.5, 1 , 24, 48 and 72 hours after removal of the dressing and then on day 7, 14 in order to observe their reversibility. The mean values of the scores for erythema and oedema were calculated for each animal.

The mean scores over 24, 48 and 72 hours for individual animals were 2.0, 1.0, and 0.3 for erythema and 0.0, 0.0, and 0.0 for oedema and all reactions reversed within 14 days. Oedema were not observed. In addition, the treated skin sites were sporadically dry-rough, discoloured light brown and fine or coarse scales occurred during the observation period of 14 days. Based on the study results, the test material is not subject to labelling requirements with regard to skin irritation..