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 1988-02-09 to 1988-03-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Reliability scoring based on 1981 guideline for test n°404
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Genamin SH 301
IUPAC Name:
Genamin SH 301
Constituent 2
Reference substance name:
Amines, di-C14-18-alkylmethyl
EC Number:
266-923-8
EC Name:
Amines, di-C14-18-alkylmethyl
Cas Number:
67700-99-6
IUPAC Name:
N-hexadecyl-N-methylhexadecan-1-amine
Details on test material:
- Name of test material (as cited in study report): Genamin SH 301
- A statement of identity for Genamin SH 301 was provided on june 2009 by the sponsor Clariant Produkte GmbH (see attached background material). The statement specifies that the following chemical names, CAS registration and EC numbers are appropriate synonyms to describe GENAMIN SH 301:
-> Amines, bis(hydrogentated tallow alkyl)methyl CAS 61788-63-4 EC 262-991-8
-> Amines, di-C14-18-alkylmethyl CAS 67700-99-6 EC 266-923-8
- Physical state: red dark colored cream
- Lot/batch No.: HTWC 255 0000
- Storage condition of test material: At 22 °c, in darkness
- Purity: 100%
- Density: 0.81 kg/l at 50 °C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.5-3.5 kg
- Diet and water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature : 17-23 °C
- Humidity: 30-70 %

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: each animal served as its own control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
30 min, 60 min, 24, 48, 72 hrs and 7d, 14d, 21d after removal the patch
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: skin of the back
- % coverage: 2.5 cm x 2.5 ccm
- Type of wrap if used: semi-occlusive

SCORING SYSTEM: according to OECD guideline 404

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:
3
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:
1.3
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:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean of the 24, 48 and 72-hour readings
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema 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: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean of the 24, 48 and 72-hour readings
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
For raw data see table 1 in the "remarks on results" freetext.

Any other information on results incl. tables

Moderate to severe erythema and very slight oedema were observed for up to 72 hours after removal of the dressing. Erythema and oedema had reversed by day 14 and 7, respectively. At the end of the observation period (21 days), 1 animal had still alopecia.

No ulceration or necrosis was observed.

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

Erythema

Oedema

Animal No

1

2

3

1

2

3

After
0.5 - 1 h

3

2

2

1

1

1

After 24 h

3

2

2

1

1

0

After 48 h

3

1

2

1

1

1

After 72 h

3

1

2

1

1

1

Mean score 24-72 h

2.1

0.9

Day 7

2

1

1

0

0

0

Day 14

0

0

0

0

0

0

Day 21

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Directive 67/548/EEC
Conclusions:
Under these experimental conditions and according to directive 67/548/EEC, the tested substance Genamin SH 301 is classified as a skin irritant.
Executive summary:

The potential of Genamin SH 301 to induce skin irritation was assessed in 3 rabbits according to the OECD guideline 404 and in compliance with the principles of Good Laboratory Practice regulations.

A single dose of 0.5 mL undiluted Genamin SH 301 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 hour, 24, 48 and 72 hours after removal of the dressing and then on day 7, 14 and 21 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 3.0, 1.3, and 2.0 for erythema and 1.0, 1.0, and 0.7 for edema. No ulceration of necrosis was noted. Erythema and edema had reversed by day 14 and by day 7, respectively.