Reaction products of amines, dicoco alkyl and glycollic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004_06_15 to 2006_02_03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP, guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Remarks:

2002-12-02

Test material

Test material information

Constituent 1

Details on test material:

- Physical state: dark amber slightly viscous liquid
- Analytical purity: No data
- Stability under test conditions: undetermined
- Storage condition of test material: 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: David Percival Ltd., Moston, Sandbach, Cheshire UK
- Age at study initiation: 12 to 20 weeks
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually housed in suspended cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr):at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light: 12 hours dark

IN-LIFE DATES: From: 2005-10-27 To: 2005-11-10

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated site on test animals used as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL
- Concentration (if solution): Applied as supplied

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours, 7 and 14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: cotton gaze secured with surgical adhesive tape and wrapped with elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): swabbed with cottn wool soaked in liquid paraffin.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

2

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.78

Max. score:

2

Reversibility:

fully reversible

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.89

Max. score:

1

Reversibility:

fully reversible

Irritant / corrosive response data:

Well defined erythema was noted at one treated site with very slight erythema at the two remaining skin sites one hour aftre patch removal. Well-defined erythema was noted at all treated skin sites at the 24, 48 and 72-hour observations.
Very slight oedema was noted at all treated skin sites one hour after ptch removal and at the 24, 48 and 72-hour observations.
Light brown discolouration was noted at all treated skin sites at the 72-hour observation with crust formation noted at the 7-day observation.
All treated skin sites appeared normal at the 14-day observation.

Any other information on results incl. tables

Table 1: Individual Skin Reactions – Test sites

Skin reaction	Observation time	Individual scores – Rabbit number and sex			Total
		153 male	154 Male	155 Male
Erythema/Eschar formation	1 hour	2	1	1	(4)
	24 hours	2	2	2	6
	48 hours	2Br	2	2	(6)
	72 hours	0Cf	2Br	2Br	6
	7 days	0	0Cf	0Cf	(0)
	14 days	1	0	0	(0)
Oedema formation	1 hour	1	1	1	(3)
	24 hours	1	1	1	3
	48 hours	1	1	1	(3)
	72 hours	0	1	1	3
	7 days	0	0	0	(0)
	14 days	0	0	0	(0)
Sum of 24 and 72-hour readings			18
Primary Irritation Index (S/6)			18/6 = 3.0
Classification			MODERATE IRRITANT

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

Br = Light brown discoloration of the epidermis

Cf = Crust formation

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material does not meet the criteria for classification as a skin irritant as defined in the EU CLP Regulation (EC) No. 1272/2008 under the conditions of the study.

Executive summary:

Test Guidance

OECD Guideline No. 404 and EC Method B4

Method and materials

0.5 mL of the test material was applied as supplied to the shaved skin of three albino New Zealand rabbits. An untreated site on the rabbits served as a control. After 4 hours exposure the semiocclusive wrapping was removed and treated sites washed with liquid paraffin. Irritation was recorded using the Draize scale at 1, 24, 48 and 72 hour time points and thereafter at 7 and 14 days.

Results

Application of the test material produced well-defined erythema and very slight oedema. Other skin reactions noted were light brown discolouration of the epidermis and crust formation. All treated skin sites appeared normal at the 14 -day observation.

No evidence of skin irritation was observed on the control patches of the three rabbits.

Under EU Directive 2001/59/EC the test material was labelled as Xi, R38 Irritating to skin.

Conclusion

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.