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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 15 April 2010 and 29 April 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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification: Bis (2-hydroxyethyl) coco alkylamine (CAS Number 61791-31-9)
Description : pale brown viscous liquid
Batch number : S-001016
Date received : 08 July 2009
Expiry date : 26 June 2017
Storage conditions: approximately 4°C in the dark under nitrogen

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
One New Zealand White rabbit was supplied by Harlan Laboratories U.K. Ltd., Loughborough, UK. At the start of the study the animal weighed 2.79 kg and was twelve to twenty weeks old. After an acclimatisation period of at least five days the animal was given a number unique within the study which was written with a black indelible marker pen on the inner surface of the ear and on the cage label.

The animal was housed in a suspended cage. Free access to mains drinking water and food (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, axon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

The animal was provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Test system

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

- Concentration (if solution):
Not applicable.

VEHICLE
Not applicable.

- Concentration (if solution):
Not applicable.

- Lot/batch no. (if required):
Not given in study report.
Duration of treatment / exposure:
3-Minutes, 1-Hour and 4-Hours
Observation period:
14 days
Number of animals:
1
Details on study design:
TEST SITE
- Area of exposure:
On the day of the test three suitable sites were selected on the back of the 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.


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:
3 minutes, 1 hour and 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).
Additional observations were made on Days 7 and 14 to assess the reversibility of skin reactions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 4
Max. score:
4
Reversibility:
not reversible
Remarks:
Corrosive effects noted
Remarks on result:
other: Max score not really applicable due to corrosive effects
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
> 4
Reversibility:
not reversible
Remarks:
Irreversible effetcs noted
Remarks on result:
other: Evaluation of oedema not possible due to adverse dermal reactions
Irritant / corrosive response data:
The individual scores for erythema/eschar and oedema are given in remarks on results including tables and figures.
3-Minute Exposure Period

The scores for erythema/eschar and oedema are given in Table 1.
Very slight erythema was noted at the treated skin site at the 24, 48 and 72 Hour observations.
The treated skin site appeared normal at the 7-Day observation.

1-Hour Exposure Period

The scores for erythema/eschar and oedema are given in Table 1.
Very slight erythema was noted at the treated skin site immediately and one hour after patch removal with well-defined erythema and slight oedema
noted at the 24, 48 and 72 Hour observations. The erythema extended approximately 2 cm beyond the test site at the 24, 48 and 72 Hour
observations. Very slight erythema, very slight oedema and severe desquamation were noted at the treated skin site at the 7 Day observation. Slight desquamation was noted at the treated skin site at the 14 Day observation.

4-Hour Exposure Period

The scores for erythema/eschar and oedema are given in Table 2.
Moderate to severe erythema and slight oedema were noted at the treated skin site immediately and one hour after patch removal. A hardened, dark
brown/black coloured scab, preventing accurate evaluation of erythema and oedema, was noted at the treated skin site at the 24, 48 and 72 Hour and 7 Day observations. Well-defined erythema surrounding the scab was noted at the 24, 48 and 72 Hour observations. Thickening of the skin was
noted at the treated skin site at the 14-Day observation.

Any other information on results incl. tables

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

Table1              Individual Skin Reactions Following 3-Minute and 1-Hour Exposures

Skin Reaction

Observation Time
(following patch removal)

Individual Scores - Rabbit Number and Sex

69076

3-Minute Exposure

1-Hour Exposure

Erythema/Eschar Formation

Immediately

0

1

1 Hour

0

1

24 Hours

1

2R

48 Hours

1

2R

72 Hours

1

2R

7 Days

0

1D

14 Days

0

0D*

Oedema Formation

Immediately

0

0

1 Hour

0

0

24 Hours

0

2

48 Hours

0

2

72 Hours

0

2

7 Days

0

1

14 Days

0

0


R=      Erythema extends approximately 2 cm beyond the test site

D =      Severe desquamation

D* =     Slight desquamation

Table2          Skin Reactions Following 4-Hour Exposure

Skin Reaction

Observation Time
(following patch removal)

Individual Scores – Rabbit Number and Sex

69076Male

Erythema/Eschar Formation

Immediately

3

1 Hour

3

24 Hours

?eStWe

48 Hours

?eStWe

72 Hours

?eStWe

7 Days

?eSt

14 Days

0Th

Oedema Formation

Immediately

2

1 Hour

2

24 Hours

?od

48 Hours

?od

72 Hours

?od

7 Days

?od

14 Days

0


St=    Hardened dark brown/black coloured scab

Th =    Thickening of the skin

We =  Well-defined erythema surrounding other skin reactions

?e =    Adverse skin reactions prevent accurate evaluation of erythema

?od =  Adverse skin reactions prevent accurate evaluation of oedema


The test material was classified as CORROSIVE to rabbit skin.

The test material was also classified as corrosive to rabbit skin according to EU labelling regulations Commission Directive 2001/59/EC. The symbol “C”, the indication of danger “Corrosive” and the risk phrase R 34 “CAUSES BURNS” are therefore required.

Iirreversible alteration of the dermal tissue noted. Test material is classified as corrosive to rabbit skin. Classification according to Draize, therefore, not be applicable.


Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Remarks:
Migrated information
Conclusions:
The test material was classified as CORROSIVE to rabbit skin.

The test material was also classified as corrosive to rabbit skin according to EU labelling regulations Commission Directive 2001/59/EC. The symbol “C”, the indication of danger “Corrosive” and the risk phrase R 34 “CAUSES BURNS” are therefore required.
Executive summary:

Introduction. 

The study was performed to assess the irritancy potential of the test material 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 Commission Regulation (EC) No. 440/2008

Results. 

3-minute and 1-hour semi-occluded applications of the test material to the intact skin of one rabbit produced no corrosive effects.

A single 4-hour, semi-occluded application of the test material to the intact skin of one rabbit produced moderate to severe erythema, slight oedema and a hardened, dark brown/black coloured scab which prevented accurate evaluation of erythema and oedema. Well-defined erythema surrounding the scab was also noted. Thickening of the skin was noted at the 14-Day observation.

Conclusion. 

The test material was classified as CORROSIVE to rabbit skin.

The test material was also classified as corrosive to rabbit skin according to EU labelling regulations Commission Directive 2001/59/EC. The symbol “C”, the indication of danger “Corrosive” and the risk phrase R 34 “CAUSES BURNS” are therefore required.