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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
4 rabbits were dermally exposed to the test material for 24 hr and then observed for 10 days. The study was repeated with 3 new rabbits with an observation period of 14 days.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylundecanal
EC Number:
203-765-0
EC Name:
2-methylundecanal
Cas Number:
110-41-8
Molecular formula:
C12H24O
IUPAC Name:
2-methylundecanal
Specific details on test material used for the study:
- Names of test material: RIFM 71-16, aldehyde C-12 MNA
- Substance type: Clear liquid
- Physical state: Liquid

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 data
- Weight at study initiation: 2.8 to 3.0 kg
- Fasting period before study: No data
- Housing: No data
- Diet: No data
- Water: No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod: No data

Test system

Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 10 mL/kg
Duration of treatment / exposure:
24 hr
Observation period:
10 days (test group 1)
14 days (test group 2)
Number of animals:
2 male, 2 female (test group 1)
2 male, 1 female (test group 2)
Details on study design:
TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: damming

REMOVAL OF TEST SUBSTANCE
- Washing: With water
- Time after start of exposure: 24 hr

SCORING SYSTEM:
- Not explicitly stated, although scoring can be presumed to be the standard scoring system of Draize (1959), and this matches details given in the text.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Reversibility:
not fully reversible within: 10 d
Remarks on result:
other: 10 day observation period
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Reversibility:
not fully reversible within: 10 d
Remarks on result:
other: 10 day observation period
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 10 d
Remarks on result:
other: 10 day observation period
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Reversibility:
not fully reversible within: 10 d
Remarks on result:
other: 10 day observation period
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Reversibility:
not fully reversible within: 10 d
Remarks on result:
other: 10 day observation period. Oedema was replaced by a shell of hard peeling skin by day 7.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Reversibility:
not fully reversible within: 10 d
Remarks on result:
other: 10 day observation period. Oedema was replaced by a shell of hard peeling skin by day 7
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: 10 day observation period
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: 10 day observation period
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 14 d
Remarks on result:
other: 14 day observation period
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Reversibility:
not fully reversible within: 14 d
Remarks on result:
other: 14 day observation period
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 14 d
Remarks on result:
other: 14 day observation period
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: 14 day observation period
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Reversibility:
fully reversible within: 6 d
Remarks on result:
other: 14 day observation period. Oedema was replaced by a shell of hard peeling skin by day 6.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: 14 day observation period
Irritation parameter:
erythema score
Basis:
mean
Remarks:
All animals
Time point:
24/48/72 h
Score:
3.25
Remarks on result:
other: 10 day observation period
Irritation parameter:
edema score
Basis:
mean
Remarks:
All animals
Time point:
24/48/72 h
Score:
2.25
Remarks on result:
other: Observation period 10 days

Any other information on results incl. tables

For full details on results, see the attached supporting material.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
In accordance with the classification criteria set out in CLP Regulation (EC) no. 1272/2008 the results obtained for both experiments determine that the test material 2-methylundecanal should be classified as a Category 2 skin irritant.