Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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

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

Resultsopen allclose all
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.