Registration Dossier

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:
2012-04-30 to 2012-06-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: (Tetrapropylensuccinimido)-caproic acid
Product (common name/code): Hostacor 4221
Batch No.: 12-YS032
Chemical Name: (Tetrapropylensuccinimido)-capronic acid
Purity (qualitative and quantitative): 100%
Physical State at RT: liquid
Active Components: 98%
Colour: brown
Expiry Date: 17.04.2014
Storage Conditions: room temperature
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Housing and Feeding Conditions:
- Semi barrier in an air-conditioned room
- Temperature: 18 +/- 3 °C (recommendations of TVT, GV-SOLAS)
- Relative humidity: 55 +/- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: at least 10 x / hour
- Free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 1410), rich in crude fibre
- Free access to tap water (drinking water, municipal residue control, microbiological controls at regular intervals)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Housed in ABS - plastic rabbit cages, floor 4200 cm2
- Adequate acclimatisation period (at least 5 days) under laboratory conditions

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A dose of 0.5 mL of the test item was applied to each test site.
Duration of treatment / exposure:
The test item was held in contact with the skin throughout a 4-hour period.
At the end of the exposure period, the residual test item was removed with
aqua ad injectionem (Diprom, lot no. 10952-1, expiry date: 09/2013).
Observation period:
All animals were observed for 72 hours after the patch removal.
Number of animals:
3
Details on study design:
Clinical Observation:
The animals were examined for signs of erythema and oedema 1 hour after the patch removal.
For the determination of classification-relevant values, the animals were examined for signs of
erythema and oedema 24, 48 and 72 hours after the patch removal. Dermal irritation was scored a
nd recorded according to the grades in the table below. Any other signs such as hyperplasia, scaling,
discolouration, fissures and scabs or any systemic effects were also recorded.
For the initial test in one animal, the test site was also examined immediately after the patch had been removed.

Evaluation of Results:
Individual reactions of each animal were recorded at each time of observation.
Nature, severity and duration of all lesions observed were described.
The body weight development was recorded at the start and at the end of the study.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
No irritant or corrosive effects were observed on the intact skin of the three female rabbits (strain NZW) after a contact time of 4 hours.

Other effects:
Neither mortalities nor significant clinical signs of toxicity were observed.
There were no significant body weight changes during the contact and observation period.

Any other information on results incl. tables

Table: Dermal Irritation Evaluation

Animal
No.

Application
Site

Irritation (hours after patch removal)

1 hour

24 hours

48 hours

72 hours

T

C

T

C

T

C

T

C

1

Erythema

0

0

0

0

0

0

0

0

Oedema

0

0

0

0

0

0

0

0

2

Erythema

0

0

0

0

0

0

0

0

Oedema

0

0

0

0

0

0

0

0

3

Erythema

0

0

0

0

0

0

0

0

Oedema

0

0

0

0

0

0

0

0

Table: Individual Data

Individual Systemic and Local Findings - Animal No. 1

Time after
Patch Removal

Systemic Findings

Specific Local Findings (apart from erythema/oedema)

Comments

1 hour

nsf

nsf

-

24 hours

nsf

nsf

-

48 hours

nsf

nsf

-

72 hours

nsf

nsf

-

Individual Systemic and Local Findings - Animal No. 2

Time after
Patch Removal

Systemic Findings

Specific Local Findings (apart from erythema/oedema)

Comments

1 hour

nsf

nsf

-

24 hours

nsf

nsf

-

48 hours

nsf

nsf

-

72 hours

nsf

nsf

-

Individual Systemic and Local Findings - Animal No. 3

Time after
Patch Removal

Systemic Findings

Specific Local Findings (apart from erythema/oedema)

Comments

1 hour

nsf

nsf

-

24 hours

nsf

nsf

-

48 hours

nsf

nsf

-

72 hours

nsf

nsf

-

Table: Absolute Body Weights in kg

 

Animal No. 1

Animal No. 2

Animal No. 3

Start of Study
(weight in kg)

3.8

3.5

4.4

End of Study
(weight in kg)

3.8

3.6

4.5

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The registration substance was investigated for its skin irritation potential according to the OECD Guideline 404. The registration substance is not irritating.
Executive summary:

The registration substance was investigated for its skin irritation potential according to the OECD Guideline 404. The registration substance is not irritating. The obtained scores were zero for erythema as well as for oedema.