Reaction mass of pentadecylamine and tridecylamine and 2-Methyldodecylamine and 2-Methyltetradecylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January and February 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study based on national and scientific standards, basic data given, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: SOP No. CT20-137, version 01 (ICI)

Principles of method if other than guideline:

reduced exposure time, below 4 h

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Amines, C12-18-alkyl

EC Number:

268-953-7

EC Name:

Amines, C12-18-alkyl

Cas Number:

68155-27-1

Molecular formula:

mixture of C13 [C13H29N] and C15 [C15H33N]-branched and linear amines

IUPAC Name:

Amines, C12-18-alkyl

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Synprolam 35 (trade name)
- Substance type: organic
- Physical state: liquid, clear
- Melting point: 12.5 °C
- Boiling point: 263 °C
- Density: 0.806 g/mL (20 °C)
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data in the Report
data adopted from the precursor aldehyde mixture (SYNPRAL 135):
- n-tridecylamine 33 % (m/m)
- isotridecylamine 33 % (m/m)
- n-pentyldecylamine 14 % (m/m)
- isopentylamine 14 % (m/m)
- other components 6 % (m/m)

[Reference: ICI 1975/1976: Synthetic fatty amines - Synpral 135 (Synprolaldehyde; C13/C15 alkyl aldehyde). MSDS]

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

not specified

Preparation of test site:

other: shaved, intact and abraded

Vehicle:

unchanged (no vehicle)

Controls:

not required

Duration of treatment / exposure:

1 h and 3 min

Observation period:

1, 4, 24, 48, and 96 h (after 1-h exposure),
4, 24, 48, and 72 h (after 3-min exposure)

Number of animals:

6 each

Details on study design:

no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Remarks:

necrosis

Basis:

other: 2/6 animals (1-h exposure)

Time point:

other: 4 h p.a.

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: corrosive: => not quantitively evaluable, descriptive rating: Scores are surrogates.

Results 2

Irritation parameter:

overall irritation score

Remarks:

necrosis

Basis:

other: 6/6 animals (1-h exposure)

Time point:

other: 24, 48, and 96 h p.a.

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: corrosive: => not quantitively evaluable, descriptive rating: Scores are surrogates.

Results 3

Irritation parameter:

overall irritation score

Remarks:

necrosis

Basis:

other: 5/6 animals (3-min exposure)

Time point:

other: 4 h p.a.

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: corrosive: => not quantitively evaluable, descriptive rating: Scores are surrogates.

Results 4

Irritation parameter:

overall irritation score

Remarks:

necrosis

Basis:

other: 6/6 animals (3-min exposure)

Time point:

other: 24, 48, and 72 h p.a.

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: corrosive: => not quantitively evaluable, descriptive rating: Scores are surrogates.

Results 5

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the corrosivity no erythema score could be derived.

Results 6

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the corrosivity no erythema score could be derived.

Results 7

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the corrosivity no erythema score could be derived.

Results 8

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the corrosivity no erythema score could be derived.

Results 9

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the corrosivity no erythema score could be derived.

Results 10

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the corrosivity no erythema score could be derived.

Results 11

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the corrosivity no edema score could be derived.

Results 12

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the corrosivity no edema score could be derived.

Results 13

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the corrosivity no edema score could be derived.

Results 14

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the corrosivity no edema score could be derived.

Results 15

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the corrosivity no edema score could be derived.

Results 16

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the corrosivity no edema score could be derived.

Irritant / corrosive response data:

After exposure of 1 h, tissue destruction was observed in 2/6 animals after 4 h post-application and in all animals at 24 through 96 h It was characterised by thickened, dark, necrotic skin with slight hardening and surrounded by an area of blanched skin edged with erythematous skin.
After exposure of 3 min, similar signs of tissue destruction were observed 4 h post-application.

Any other information on results incl. tables

Observations after 3 -minute application:

Test Site	Ratio of 6 Rabbits
	4 hr	24 hr	48 hr	96 hr
Abraded	5/6	6/6	6/6	6/6
Intact	5/6	6/6	6/6	6/6

Observations after 1 -hour application:

Test Site	Ratio of 6 Rabbits
	1 hr	4 hr	24 hr	48 hr	96 hr
Abraded	0/6	2/6	6/6	6/6	6/6
Intact	0/6	2/6	6/6	6/6	6/6

Applicant's summary and conclusion

Interpretation of results:

Category 1A (corrosive) based on GHS criteria

Conclusions:

The test item caused corrosive responses under the conditions of this test.

Executive summary:

The effect of the test item on rabbit skin was assesed in oder to classify the potential corrosivity according to standard operating procedure no. CT20 -137, Version 01.

In a first study, the test item was applied for one hour on abraded and intact skin of six rabbits, respectivetly. Tissue destruction was observed in two out of six animals at 4 hours and in all six animals at 24 hours after application. It was characterised by thickened, dark, necrotic skin with slight hardening and surrounded by an area of blanched skin edged with erythematous skin.

Similar signs of tissue destruction were observed 4 hours after a 3 -minute application of the test item.