Amines, di-C16-18-alkyl

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30-09-1987 until 24-11-1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

see remarks below

Principles of method if other than guideline:

More animals tested than guideline.
Only 4 hr exposure tested.

GLP compliance:

no

Remarks:

pre-GLP, but inhouse Quality Assurance

Test material

Test material information

Constituent 1

Reference substance name:

N-(C16-C18)alkyl(C16-C18)alkane-1-amine

EC Number:

629-721-4

Cas Number:

308062-60-4

Molecular formula:

No molecular formula

IUPAC Name:

N-(C16-C18)alkyl(C16-C18)alkane-1-amine

Test material form:

solid

Details on test material:

Chemical name: Amines, di-C16-18 (even numbered) alkyl
EC no.: 629-721-4

To the best of knowledge, the sample used is representative to the boundary composition shared and agreed by each registrant.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield rabbits, Peterfield, Hampshire, United Kingdom
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 2.0 - 2.8 kg
- Housing: individually in metal cage with perforated floor
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19
- Humidity (%): 30 - 70
- Air changes (per hr): 19 changes/hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 g moistened with 0.5 ml distilled water

Duration of treatment / exposure:

4 hours

Observation period:

0.5 hr after removal of patches and 24, 48 and 72 hours later. Additional observations were made on day 5 through 8.

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5cm x 2.5 cm
- Gauze pad, occluded with Elastoplast elastic adhesive dressing (semi occlusive)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
- see table below.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals 4 hrs exposure

Time point:

24/48/72 h

Score:

1.6

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals 4 hrs exposure

Time point:

24/48/72 h

Score:

1.5

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritant / corrosive response data:

At the end of the four hour exposure period very slight to moderate irritation was observed in all six animals. These reactions persisted
in five animals up to and including Day 6. The reactions had resolved completely in one animal by Day 2 and in three by Day 7.
Very slight erythema, accompanied in one animal by desquamation of the stratum corneum, persisted in two animals on Day 7, but had resolved
by the following day.

Any other information on results incl. tables

Summary of dermal lesions (following 4-h application)

no.	Effect	Hour	Days after application						Mean score erythema 24/48/72 h	Mean score oedema 24/48/72 h
		0.5	1	2	3	4	5	6
2636	Erythema/ eschar Oedema	2 2	2 2	2 2	2 2	2 3	2 2	1D 0	2	2
2637	Erythema/ eschar Oedema	2 2	2 3	2 3	2 1	2 2	2 1	0 0	2	2.3
2638	Erythema/ eschar Oedema	1 1	1 1	1 1	1 0	1 1	1 1	0 0	1	0.7
2639	Erythema/ eschar Oedema	2 3	2 3	2 3	3 2	3 2	2 2	1 0	2.3	2.7
2640	Erythema/ eschar Oedema	2 1	2 1	2 1	2 1	1 1	1 1	0 0	2	1
2641	Erythema/ eschar Oedema	2 1	0 0						0	0
Mean									1.6	1.5

Fa = abnormal fur growth; Fr = reduced fur growth; D = desquamation; T = thickening of skin; R= reactions extending beyond treatment site; Hy = hyperkeratinisation; Br = brown discolourisation of skin; L = loss of skin suppleness; H = haemorrhage of dermal capillaries; Gr = green discoulorisation of skin; Tf = transverse folding of skin; Fi = fissuring of skin; Sc = small scattered scabs; Gs = glossy skin

On day 7 all scores were 0.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The mean erythema score was 2.3 for one animal. But majority of animals between 1.5 and 2.3.
The mean oedema score was for only two animals 2.3 and 2.7.
No signs of necrosis. Full reversibility.

Executive summary:

A study was performed to assess the effects of Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) on the irritancy potential to the skin of the New Zealand White rabbit. The method used was based on that described in the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion".

A 4 hours, semi-occluded dermal application of the test material to the intact skin of three rabbits followed by a decontamination procedure with water produced irritation scores directly after patch removal and 1,2 and 3 days afterwards. The erythema/eschar effects were fully reversible within 7 days, the oedema effects were fully reversible in 6 days.