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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
21/12/2009 - 19/02/2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
Please refer to the Amine Oxide Category justification attached in Section 13

2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL
Please refer to the Amine Oxide Category justification attached in Section 13
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Amines, C12-18(even numbered)-alkyldimethyl, N-oxides
EC Number:
931-341-1
Molecular formula:
CnH(2n+3)NO, where n=14-20
IUPAC Name:
Amines, C12-18(even numbered)-alkyldimethyl, N-oxides
Test material form:
solid - liquid: aqueous solution
Details on test material:
- Name of test material (as cited in study report): Aromox B-W 500
- Substance type: C12-18 alkyldimethylamine oxide
- Physical state: Liquid
- Composition of test material, percentage of components: 32 %w/w amine oxide, 68 %w/w water
- Lot/batch No.: S001396
- Expiration date of the lot/batch: June 15, 2018
- Storage condition of test material: At room temperature, dry. After use, nitrogen gas was added before closing the container to prevent oxidation

Test animals

Species:
rat
Strain:
other: CD/Crl: CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services Germany GmbH
- Age at study initiation: males 7 weeks; females 9 weeks
- Weight at study initiation: males 221-235 g; females 206-224 g
- Fasting period before study: 16 hours
- Housing: Housed singly during the 14 day observation period in Makrolon cages
- Diet (e.g. ad libitum): ssniff R/M-H V1534
- Water (e.g. ad libitum): ad libitum
- Acclimation period:at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 7/01/2010 - 3/02/2010

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: animals back, 5x6 cm
- % coverage: approx 10 % of body surface
- Type of wrap if used: 8 layers of gauze covered with a plastic sheet and secured with adhesive plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not applicable
- Time after start of exposure: not applicable

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw
- Concentration (if solution): not stated
- Constant volume or concentration used: yes

Duration of exposure:
24 hours
Doses:
2000 mg AO/kg bw
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. During the 14 day observation period observed at least once daily until all symptoms subsided and daily thereafter. Bodyweight recorded before administration and thereafter in weekly intervals up to the end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:
No preliminary study performed
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No deaths seen during the study
Clinical signs:
other: No clinical signs seen during the study
Gross pathology:
No macroscopic changes were noted at necropsy
Other findings:
- Other observations: Erythema (grade 2-4) was observed at the application site in all 5 males and 5 females immediately after patch removal until test day 6 No oedema was observed in any animals. All reactions cleared by Day 7.

Any other information on results incl. tables

Table 1: Skin reactions observed during the study

Animal No. & sex

Skin reactions on test day

 

1

2

3

4

5

6

7

 

 

E/Oe/N

E/Oe/N

E/Oe/N

E/Oe/N

E/Oe/N

E/Oe/N

1 m

 

2/0/0

2/0/0

3/0/0

4/0/0

4/0/0

0/0/0

2 m

 

2/0/0

2/0/0

3/0/0

4/0/0

4/0/0

0/0/0

3 m

 

2/0/0

0/0/0

3/0/0

4/0/0

4/0/0

0/0/0

4 m

 

2/0/0

2/0/0

3/0/0

4/0/0

4/0/0

0/0/0

5 m

 

2/0/0

2/0/0

3/0/0

4/0/0

4/0/0

0/0/0

6 f

 

2/0/0

2/0/0

3/0/0

4/0/0

4/0/0

0/0/0

7 f

 

2/0/0

2/0/0

3/0/0

4/0/0

4/0/0

0/0/0

8 f

 

2/0/0

2/0/0

3/0/0

4/0/0

4/0/0

0/0/0

9 f

 

2/0/0

2/0/0

3/0/0

4/0/0

4/0/0

0/0/0

10 f

 

2/0/0

2/0/0

3/0/0

4/0/0

4/0/0

0/0/0

Animal No. & sex

Skin reactions on test day

 

8

9

10

11

12

13

14

 

 

E/Oe/N

E/Oe/N

E/Oe/N

E/Oe/N

E/Oe/N

E/Oe/N

1 m

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

2 m

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

3 m

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

4 m

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

5 m

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

6 f

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

7 f

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

8 f

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

9 f

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

10 f

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

m = male         E = erythema   N = necrosis

f = female         Oe = Oedema   0 = no pathological findings

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of C12-18 amine oxide is > 2000 mg AO/kg bw
Executive summary:

The acute dermal toxicity of the substance was investigated in a GLP study performed to OECD 402. The substance was applied as a solution in water to the skin of 5 male and 5 female rats (CD/Crl: CD(SD)) at a dose of 2000 mg AO/kg bw and covered with an occlusive dressing for 24 hours. After completion of the exposure period the dressing was removed. There were no deaths or signs of systemic toxicity during the 14 -day observation period and animals showed the expected bodyweight gains. Erythema (grade 2-4) was observed at the application site in all 5 males and 5 females immediately after patch removal until test day 6. No Oedema was noted at any time period. All reactions cleared after 7 days. Necropsy revealed no macroscopic findings. The LD50 was 2000 mg AO/kg bw.