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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study conducted similarly to OECD Guideline 402 with deviations: purity of test substance, details on test animals and environmental conditions not reported, 2/sex/dose instead of 5/sex/dose

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
purity of test substance, details on test animals and environmental conditions not reported, 2/sex/dose instead of 5/sex/dose
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-hydroxy-3-[(1-oxodocosyl)oxy]propyltrimethylammonium chloride
EC Number:
274-033-6
EC Name:
2-hydroxy-3-[(1-oxodocosyl)oxy]propyltrimethylammonium chloride
Cas Number:
69537-38-8
Molecular formula:
C28H58NO3.Cl
IUPAC Name:
3-(docosanoyloxy)-2-hydroxy-N,N,N-trimethylpropan-1-aminium chloride
Constituent 2
Chemical structure
Reference substance name:
2-methylpentane-2,4-diol
EC Number:
203-489-0
EC Name:
2-methylpentane-2,4-diol
Cas Number:
107-41-5
Molecular formula:
C6H14O2
IUPAC Name:
2-methylpentane-2,4-diol
Test material form:
solid
Remarks:
paste
Details on test material:
- Description: White pasty product
- Date of receipt: 10 September 1980

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Test substance was applied to a large surface of the skin at 0 (control), 5, 10 or 100% at 9 mL/kg bw of the rabbits during 24 hours. Each of the doses was applied to two male and two female rabbits. In each dose group one male and one female received the test substance on the intact skin, while the other male and female was treated on the superficially damaged skin.
Duration of exposure:
24 hours
Doses:
5, 10 and 100% at 9 mL/kg bw
No. of animals per sex per dose:
2 animals/sex/dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: After exposure, the animals were observed for a period of 14 days. Body weights, and intake of food and water were recorded. At day 14, blood samples were collected for examination of haematological parameters.
- Necropsy of survivors performed: Yes, at the end of observation period, animals were sacrificed and examined for gross pathological changes.
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 9 mL/kg bw
Based on:
test mat.
Remarks on result:
other:
Remarks:
as the relative density of test substance is equal to 1.011 at 20°C, the LD50 is higher than 9099 mg/kg bw
Mortality:
One rabbit in the lowest dose group and one of the controls died from causes apparently unrelated to treatment. No deaths occurred in the intermediate and high dose group.
Clinical signs:
No clinical signs were observed.
After the 24-hour exposure period only one top-dose rabbit showed signs of skin irritation.
Gross pathology:
At autopsy of the survivors no gross changes attributable to the test substance were observed.
Other findings:
Body weight gain, food and water consumption and haematology did not show any treatment-related changes.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the dermal LD50 of test substance is higher than 9 mL/kg bw or 9099 mg/kg bw.
Executive summary:

In an acute dermal toxicity study, test substance was applied to a large surface of the skin at 0 (control), 5, 10 or 100% at 9 mL/kg bw of the NewZealand White rabbits (2/sex/dose) during 24 hours. In each dose group one male and one female received the test substance on the intact skin, while the other male and female was treated on the superficially damaged skin. Animals were observed for mortality, clinical signs, bodyweights, food and water consumption and haematology for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.

 

One rabbit in the lowest dose group and one of the controls died from causes apparently unrelated to treatment. No deaths occurred in the intermediate and high dose group. After the 24-hour exposure period only one top-dose rabbit showed signs of skin irritation. General condition, body weight gain, food and water consumption and haematology did not show any treatment-related changes. No abnormalities were noted at necropsy.

 

Under the test conditions, no treatment-related death was observed up to 9 mL of the undiluted product/kg bw. As the relative density of test substance is equal to 1.011 at 20°C, the dermal LD50 of test substance is higher than 9099 mg/kg bw.