Reaction mass of bis(N-decyl-N,N-dimethyldecan-1-aminium) carbonate and N-decyl-N,N-dimethyldecan-1-aminium hydrogen carbonate

Endpoint summary

Description of key information

Skin irritation
The key study was carried out according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and FIFRA 40 CFR. The study was conducted to assess the potential of a 50 % active ingredient formulation of the test material to cause irritation after one topical application to the skin of a New Zealand White male rabbit for four hours.  The test item was considered to be corrosive in this skin irritation test. 
In addition a GLP study was carried out to evaluate the dermal irritation of Didecyldimethylammonium carbonate and to provide results in the same units as those used to report human exposure, i.e. µg test substance per cm2 skin. The low observed adverse effect concentration (LOAEC) in this study was determined to be 10 µg AI/cm2/day.
Eye irritation
According to column 2 of REACH Regulation (EC) No 1907/2006 Annex VII, section 8. testing for eye irritation was waived, as the available information indicates that the criteria are met for classification as corrosive to the skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to international guidelines.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

other: FIFRA 40 CFR

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation:
- Weight at study initiation:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

0.5 - 1 hour, 24 hours

Number of animals:

1 animal

Details on study design:

TEST SITE
- Area of exposure: 1x1 inch

SCORING SYSTE
- Draize JH, 1959

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 0.5 - 1 hour

Score:

3

Max. score:

3

Reversibility:

no data

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24 hour

Score:

3

Max. score:

3

Reversibility:

no data

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 0.5 - 1 hour

Score:

4

Max. score:

4

Reversibility:

no data

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24 hour

Score:

4

Max. score:

4

Reversibility:

no data

Irritant / corrosive response data:

Severe irritation was observed in the animal 0.5 - 1 and 24 hours following application. Changes noted in the colouration and/or texture of the skin included dark and light brown, dark red and purple discolouration, blanching, coriaceousness and necrosis. Due to the evidence of corrosion (necrosis) exhibited in this single animal at the 24 hour reading, this study was terminated without testing in additional animals.

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material was considered corrosive in this skin irritation test.

Executive summary:

A study was carried out according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and FIFRA 40 CFR. The study was conducted to assess the potential of a 50 % active ingredient formulation of the test material to cause irritation after one topical application to the skin of a New Zealand White male rabbit for four hours. Signs of skin reaction were observed 0.5 - 1 hour and 24 hours post application. Severe irritation was observed. Changes noted in the colouration and/or texture of the skin included dark and light brown, dark red and purple discolouration, blanching, coriaceousness and necrosis. Due to the evidence of corrosion (necrosis) exhibited in this single animal at the 24 hour reading, this study was terminated without testing in additional animals. The test item was considered to be corrosive in this skin irritation test.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
GLP study according to international guidelines.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the information available the substance is classified and labeled as Skin Corr. 1B, H314: Causes severe skin burns and eye damage according to Regulation (EC) No 1272/2008 (CLP) and C, R34: Causes burns according to Directive 67/548/EEC (DSD).