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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Data presented as a summary report to TSCA under the Section 8 (e) Compliance Audit Programme for Reportable Adverse Effects. A full study report is not available for evaluation of the overall study reliability but the data summary presented to TSCA is adequate to determine the acute endpoint.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Principles of method if other than guideline:
Four rabbits exposed to 0.5 mL of undiluted test substance and assessment of dermal response at 72 hours after application
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
N-ethyl methyl allylamine
IUPAC Name:
N-ethyl methyl allylamine
Constituent 2
Chemical structure
Reference substance name:
N-ethylmethacrylamine
EC Number:
242-217-5
EC Name:
N-ethylmethacrylamine
Cas Number:
18328-90-0
Molecular formula:
C6H13N
IUPAC Name:
N-ethyl-2-methylprop-2-en-1-amine
Test material form:
other: clear yellowish liquid
Details on test material:
- Name of test material (as cited in study report): C-1033 (N ethyl methyl allylamine)
- Physical state: clear yellowish liquid
- Analytical purity: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data

- Storage condition of test material: 60-85°F (circa 16-30°C)
- Other: Specific Gravity stated as 0.78 g/mL

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No information
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: No information
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: animals received on 16 or 23 September or 9 December 1986 and dosed on 9 or 16 October or 31 December respectively

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room monitored over temperature range of circa 16-30°C
- Humidity (%): No information
- Air changes (per hr): No information
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: 9 October 1986 To: 7 January 1987

Test system

Type of coverage:
not specified
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL of undiluted test substance
Duration of treatment / exposure:
No data
Observation period:
Results presented for the 72 hour post-application observation point
Number of animals:
Four
Details on study design:
Four rabbits dosed with 0.5 ml of undiluted test material and observed subsequently for a dermal response based on elicitation of erythema and/or oedema

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
no indication of irritation
Irritation parameter:
other: Evidence of severe tissue damage at each of the treated sites
Basis:
other: reaction observed at each of four treated sites
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: necrosis and eschar observed at each abraded site
Irritant / corrosive response data:
All four rabbits showed evidence of severe tissue damage with grade 4 erythema, necrosis and eschar apparent with oedema also present for one rabbit. The reactions were indicative of a corrosive response.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Evidence of corrosivity was observed under the conditions of this study.
Executive summary:

Four rabbits were treated by application of 0.5 ml of undiluted C-1033 (N-ethylmethylallylamine) to abraded dermal sites. Dermal reactions were assessed after 72 hours. All four rabbits showed evidence of severe tissue damage with grade 4 erythema, necrosis and eschar apparent with oedema also present for one rabbit; evidence of corrosivity was observed under the conditions of this study.