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:
2016-10-06 to 2016-12-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

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: Coco iminodiglycinate
Chemical Name: active ingredient: Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts with CAS no 2098351-38-1
CAS No.: active ingredient: 97659-51-3
Batch No.: 1259678
Molecular Weight: 482.5 g/mol
Physical State: liquid
Colour: yellow
Density: 1.14 g/cm3
pH Value: 8.7 as 20% solution
Active Components: 30.2% Coco iminodiglycinate
59.2% water
10.6% NaCl
Purity: 40.8%
Expiry Date: 16 December 2016
Storage Conditions: room temperature
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.

Specific details on test material used for the study:
Name: Coco iminodiglycinate
Batch No.: 1259678
CAS No.: Active ingredient: CAS RN 97659-51-3
Aggregate State at RT: liquid
Color: yellow
Active Components: 30.2% Coco iminodiglycinate, 59.2% Water, 10.6% NaCl
Purity: 40.8% active ingredient
Stability: stable
Storage Conditions: room temperature
Expiry Date: 16 December 2016
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, 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 for two years at BSL Munich and afterwards archived at Eurofins Munich
- Housed in ABS-plastic or Noryl 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:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Dose Level
A dose of 0.5 g of the test item was applied to each test site.
Duration of treatment / exposure:
Exposure Period
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 sterile water.
Observation period:
Observation Period
The 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 and 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 for each animal were recorded according to the scoring system described in the table below at each time of observation.
Nature, severity and duration of clinical observations were described.
The body weight changes were summarised in a tabular form.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 0 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Neither irritant nor corrosive effects were observed on the intact skin of three male rabbits (strain NZW) after a contact time of 4 hours. Two of the three rabbits showed no effects at all for any of the dermal irritation endpoints evaluated; the third rabbit had very slight Oedema (score 1) after 24 and 48 hours, which was fully reversed after 72 hours.
Other effects:
Neither mortalities nor significant clinical signs of toxicity were observed.
There were no significant body weight changes during the observation period.

Any other information on results incl. tables

I

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of the present study, the single dermal application of the test item Coco iminodiglycinate, (Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts with CAS no 2098351-38-1) to three rabbits at a dose of 0.5 mL showed slight irritant but no corrosive effects in one animal which were fully reversible within up to 72 hours. Neither mortalities nor significant clinical signs of toxicity were observed.
Executive summary:

Summary Results

Species/strain:                               New Zealand White Rabbits Crl: KBL (NZW)

Number of animals:                               3

Duration of exposure:                          4 hours

Amount of substance:                          0.5 g per test site

Type of dressing:                                   semi-occlusive

Vehicle (moistening):                            none

First time of effects:                               animal no. 1: 24 hours after patch removalerythemagrade 1, animals no. 2 and no. 3: no effects observed

Last time of effects:                             animal no. 1: 48 hours after patch removalerythemagrade 1, animal no. 2 and no. 3: no effects observed

Reversibility of the observed effects:  no effects observed

Method:                                                 OECD 404; EC 440/2008, Method B.4; OPPTS 870.2500; OPPTS 870.1000

Average Irritation Scores – (24, 48, 72-hour reading) – and Total Mean Value

Statistic Average
Animal No. 1 Animal No. 2 Animal No. 3 Total Mean Value
Oedema Grade 0 0 0 0
Erythema Grade 0.67 0 0 0.22

Conclusion

Under the conditions of the present study, the single dermal application of the test item Coco iminodiglycinate, (Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts with CAS no 2098351-38-1) to three rabbits at a dose of 0.5 mL showed slight irritant but no corrosive effects in one animal which were fully reversible within up to 72 hours.

Neither mortalities nor significant clinical signs of toxicity were observed.