N,N'-bis{3-[di-(branched and cyclic) alkylamino]alkyl}alkanediamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014-07-08 to 2014-07-15

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Physical state: Light brown viscous liquid
- Analytical purity: 100%
- Expiration date of the lot/batch: 06 June 2016

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK.
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.45 and 2.49 kg
- Housing: Animals were individually housed in suspended cages.
- Diet: Food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: 15 air changes/hour
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: From: 2014-07-08 to 2014-07-15

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Test item was used as supplied (undiluted)
- pH of the undiluted test item: 7.0
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4h

Observation period:

Immediately following removal of the patches and approximately 1, 24, 48 and 72 h later, the sites were examined for evidence of primary irritation.
An additional observation was made on Day 7 to assess the reversibility of skin reactions.

Number of animals:

2 females

Details on study design:

TEST SITE
- Area of exposure: On the day of the test a suitable site was selected on the back of each rabbit. A quantity of 0.5 mL of the test item was applied directly to the skin under a 2.5 cm x 2.5 cm cotton gauze patch.
- Type of wrap if used: Treatment site was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing: Four hours after application the corset and patches were removed from animals and any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

probability of mild irritation

Irritant / corrosive response data:

Very slight erythema was noted at one treated skin site 1 hour after patch removal and at both treated sites at the 24, 48 and 72 hour observations.
Both treated skin sites appeared normal at the 7 day observations.
No corrosive effects were noted.

The test item produced a primary irritation index of 1.0.

Other effects:

Both animals showed expected gain in body weight during the study.

Any other information on results incl. tables

Individual skin reactions

Skin reaction	Observation Time (following patch removal)	Individual score – Rabbit number and sex		Total
		74481 Female	74482 Female
Erythema/Eschar Formation	Immediately	0	0	(0)
	1 hour	0	1	(1)
	24 hours	1	1	2
	48 hours	1	1	(2)
	72 hours	1	1	2
	7 days	0	0	(0)
Edema formation	Immediately	0	0	(0)
	1 hour	0	0	(0)
	24 hours	0	0	0
	48 hours	0	0	(0)
	72 hours	0	0	0
	7 days	0	0	(0)
Sum of 24 and 72-hour readings (S):        4
Primary Irritation Index (S/4):                     4/4 = 1.0
Classification:                                                MILD IRRITANT

 

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

Individual body weights and body weight change

Rabbit number and sex	Individual body weight (kg)		Body weight change (kg)
	Day 0	Day 7
74481 Female	2.45	2.60	0.15
74482 Female	2.49	2.66	0.17

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions the substance is not classified as irritating to skin according to the criteria of CLP Regulation (EC) No. 1272/2008.

Executive summary:

Test Guidance

OECD guideline 404 and EC Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion).

 

Method and materials

Two New Zealand White female rabbits were dermally exposed to 0.5 mL of the test material for 4 h under a semi-occlusive dressing. After removal of the residual test item, irritation was scored immediately following removal of the patches and approximately 1, 24, 48 and 72 h later, according to Draize method.

 

Results

Very slight erythema was noted at one treated skin site 1 hour after patch removal and at both treated sites at the 24, 48 and 72 hour observations.

Both treated skin sites appeared normal at the 7 day observations.

No corrosive effects were noted.

Both animals showed expected gain in body weight during the study.

The test item produced a primary irritation index of 1.0.

 

Conclusion

Under the test conditions the substance is not classified as irritating to skin according to CLP Regulation (EC) No. 1272/2008.