Amines, di-C12-18-alkylmethyl

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 September 1989 - 4 January 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

There is no information of Amines, di-C12-18-alkylmethyl (CAS No.: 68439-75-8; EC No.: 270-418-8) itself but there is information available for 1-Decanamine, N-decyl, N-methyl (CAS No.: 7396-58-9; EC No.: 230-990-1) which is structurally similar to Amines, di-C12-18-alkylmethyl.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-methyldidecylamine

EC Number:

230-990-1

EC Name:

N-methyldidecylamine

Cas Number:

7396-58-9

Molecular formula:

C21H45N

IUPAC Name:

N-decyl-N-methyldecan-1-amine

Test material form:

liquid

Details on test material:

- Chemical name: N-decyl-N-methyldecan-1-amine
- EC number: 230-990-1

“Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agree by each registrant.”

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, U.K.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.00 - 3.00 kg
- Housing: individually housed in suspended metal cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimal 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 13-21
- Humidity (%): 47-69
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: untreated flank

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

6, 4 females and 2 males

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm gauze patch
- % coverage: -
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate s i r e 2.5 crn x 4.0 cm) . To
prevent the animals interfering with the patches and ingesting the test material the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test material removed by gentle swabbing with cotton wool soaked in 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 i.e. Draize J.H. (1959) Association o f Food and Drug Officials of the United States, Austin, Texas, "The Appraisal o f the Safety of Chemicals in Foods, Drugs and Cosmetics". See below:

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

Severe dermal responses were produced. The adverse skin reaction sometimes precluded accurate evaluation of erythema and oedema. Very slight to well-defined erythema with or without very slight oedema was noted one hour after patch removal. The responses increased in severity and at subsequent observations were identified as well -defined erythema, very slight to moderate oedema, blanching of the skin, haemorrhage of the dermal capillaries, a white exudate, white raised areas of skin, thickening of the skin, scabbing, fissuring, a dry straw-coloured crust (possible hyperkeratinisation), reduced re-growth of fur, glossy skin and desquamation. No corrosive effects were noted.

Any other information on results incl. tables

Results table:

Rabbit No and sex	Region of the eye	Hours after instillation						Average 24-48-72 hours
		1	24	48	72	7	14
2 m	erythema	1R	2 RBl	2 HdRBlW	2 HdRBlW	?eThF iRSp	?eHyRSs	2
	oedema	0	3 Oe	2 R	2 R	?0d	0	2.3
5 f	erythema	2R	2R	2 RBlWEx	2 RBlWEx	?eThSkSp	?eHyRSs	2
	oedema	1	2	2 R	2 R	?0d	0	2
9 f	erythema	2R	2R	2 RBlWEx	?eBlWE	?eThFiRSp	?eHyRFr	2
	oedema	1	1	1 R	1 R	?0d	0	1
12 f	erythema	1R	2RBl	?eRBIWWe	?eRBlWExWe	?eThSkRSpp	?eDRFr	2
	oedema	0	2	2 R	2 R	?0d	0	2
21 m	erythema	2R	2HdR	2 HdBlWR	2 HdBlWR	?eThRSp	?eDRFr	2
	oedema	1	3 Oe	2 R	2 R	?0d	0	2.3
22 f	erythema	1R	2R	2 RBlW	2 RBlW	?eThFiRSp	?eRHyGFr	2
	oedema	0	3 Oe	2 R	2 R	?0d	0	2.3

Hd - General ised areas of slight haemorrhage of the dermal capillaries

(release of small amounts of blood into surrounding dermal tissue)

R - Dermal reactions extend beyond sit e of test material application

Bl - Blanching of the skin

W - White raised areas of skin

We - Well-defined erythema surrounding other adverse dermal reactions

Th  - Thickening of the skin

Ex - Exudate

St - Hardened, dark brown/black-colored scab

?e -  Unable to evaluate degree of erythema due to presence of other adverse dermal responses

Hy - Dry, straw-coloured crust, sometimes flaking from the skin

(possible hyperkeratinisation)

G - Skin glossy in appearance (keratinolysis)

Fr - Reduced re-growth of fur

Sp - Light brown-coloured scab

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Remarks:

Migrated information

Conclusions:

According to the results from this study 2 animals had a erythema or oedema score ≥ 2.3 and after 14 days the erythema score could not be read. The oedema score was fully reversible. Therefore "Cesio 28" is classified as irritating to skin (Category 2) under GHS.

Executive summary:

An acute dermal irritation/corrosion study was performed in rabbits (4 females and 2 males) according to OECD 404 and under GLP. Severe dermal responses were produced. The adverse skin reaction sometimes precluded accurate evaluation of erythema and oedema. Very slight to well-defined erythema with or without very slight oedema was noted one hour after patch removal. The responses increased in severity and at subsequent observations were identified as well -defined erythema, very slight to moderate oedema, blanching of the skin, haemorrhage of the dermal capillaries, a white exudate, white raised areas of skin, thickening of the skin, scabbing, fissuring, a dry straw-coloured crust (possible hyperkeratinisation), reduced re-growth of fur, glossy skin and desquamation. No corrosive effects were noted. According to the results from this study 2 animals had a erythema or oedema score ≥ 2.3 and after 14 days the erythema score could not be read. The oedema score was fully reverible. Therefore "Cesio 28" is classified as irritating to skin (Category 2) under GHS.