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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:
The study was performed between 13 July 2010 and 23 July 2010.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
MEA-carbamate
IUPAC Name:
MEA-carbamate
Constituent 2
Chemical structure
Reference substance name:
Carbonic acid, compound with 2-aminoethanol (1:2)
EC Number:
244-600-2
EC Name:
Carbonic acid, compound with 2-aminoethanol (1:2)
Cas Number:
21829-52-7
Molecular formula:
C2H7NO.1/2CH2O3
IUPAC Name:
carbonic acid - 2-aminoethanol (1:2)
Test material form:
liquid: viscous
Details on test material:
Sponsor's identification: MEA-carbamate
Description : pale amber coloured viscous liquid
Lot number : 1243-171
Date received : 22 December 2008
Expiry date : 22 December 2011
Storage conditions: room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
Source:
New Zealand White rabbits were supplied by an accredited supplier.

Age at study initiation:
Twelve to twenty weeks old.

Weight at study initiation:
At the start of the study the animals were in the weight range of 2.0 to 3.5 kg.

Housing:
The animals were individually housed in suspended cages.

Diet (e.g. ad libitum):
Certified Rabbit Diet. ad libitum.

Water (e.g. ad libitum):
ad libitum

Acclimation period:
At least Five days.


ENVIRONMENTAL CONDITIONS
Temperature (°C):
17 to 23°C

Humidity (%):
30 to 70%

Air changes (per hr):
The rate of air exchange was at least fifteen changes per hour.

Photoperiod (hrs dark / hrs light):
The lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
other:
Controls:
no
Amount / concentration applied:
TEST MATERIAL
Amount(s) applied (volume or weight with unit):
0.5 ml

Concentration (if solution):
Not applicable.

VEHICLE
Amount(s) applied (volume or weight with unit):
Not applicable.

Concentration (if solution):
Not applicable.

Lot/batch no. (if required):
Not given in study report.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
Area of exposure:
On the day of the test a suitable test site was selected on the back of each rabbit.

% coverage:
Not given in study report.

Type of wrap if used:
Test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in
position with a strip of surgical adhesive tape. To prevent the animal interfering with the patch, the trunk of the rabbit was wrapped in an elasticated
corset

REMOVAL OF TEST SUBSTANCE
Washing (if done):
Any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.

Time after start of exposure:
4 hours.


SCORING SYSTEM:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale (table below).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 69395 Male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No evidence of skin irritation
Irritation parameter:
erythema score
Basis:
animal: 69434 Male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No evidence of skin irritation
Irritation parameter:
erythema score
Basis:
animal: 69435 Male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No evidence of skin irritation
Irritation parameter:
edema score
Basis:
animal: 69395 Male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No evidence of skin irritation
Irritation parameter:
edema score
Basis:
animal: 69434 Male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No evidence of skin irritation
Irritation parameter:
edema score
Basis:
animal: 66110 male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No evidence of skin irritation
Irritant / corrosive response data:
The individual scores for erythema/eschar and oedema are given in remarks on results including tables and figures.
No evidence of skin irritation was noted during the study.

Any other information on results incl. tables

The individual scores for erythema/eschar and oedema are given in the following table.

Individual Skin Reactions

Skin Reaction

Observation Time
(following patch removal)

Individual Scores – Rabbit Number and Sex

Total

69395Male

69434Male

69435Male

Erythema/Eschar Formation

Immediately

0

0

0

(0 )

1 Hour

1

0

0

( 1 )

24 Hours

0

0

0

0

48 Hours

0

0

0

( 0 )

72 Hours

0

0

0

0

Oedema Formation

Immediately

0

0

0

( 0 )

1 Hour

0

0

0

( 0 )

24 Hours

0

0

0

0

48 Hours

0

0

0

( 0 )

72 Hours

0

0

0

0

Sum of 24 and 72-hour Readings (S)       :          0

Primary Irritation Index (S/6)                   :          0/6 = 0.0

Classification                                        :          NON-IRRITANT


(   ) = Total values not used for calculation of primary irritation index


The test material produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

 Interpretation of Results

Calculation of Primary Irritation Index and Grading of Irritancy Potential Using the Draize Scheme

The scores for erythema and oedema at the 24 and 72-hour readings were totalled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the test material. The test material was classified according to the following scheme devised by Draize J H (1959) "Dermal Toxicity" In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the,,, p.47:

Primary Irritation Index

Classification of Irritancy

     0

Non-irritant

> 0 to 2

Mild irritant

> 2 to 5

Moderate irritant

> 5 to 8

Severe irritant

If irreversible alteration of the dermal tissue is noted in any rabbit, as judged by the Study Director, which include ulceration and clear necrosis or signs of scar tissue, the test material is classified as corrosive to rabbit skin. Classification according to Draize may, therefore, not be applicable.


Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Draize classification scheme
Conclusions:
The test material produced a primary irritation index of 0.0 and was classified as non irritant to rabbit skin according to the Draize classification
scheme. No corrosive effects were noted.
Executive summary:

Introduction. 

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

       

 OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 24 April 2002)

  Method B4 Acute Toxicity (Skin Irritation) of CommissionRegulation (EC) No. 440/2008

Results. 

A single 4-hour, semi-occluded application of the test item to the intact skin of three rabbits produced very slight erythema at one treated skin site one hour after patch removal. No evidence of skin irritation was noted at two treated skin sites.

Conclusion.  The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted