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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 July 1995 to 3 August 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
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:
Bis(dimethyl-(2-hydroxyethyl)ammonium) 1,2-ethanediyl-bis(2-hexadecenylsuccinate)
EC Number:
421-660-1
EC Name:
Bis(dimethyl-(2-hydroxyethyl)ammonium) 1,2-ethanediyl-bis(2-hexadecenylsuccinate)
Molecular formula:
Hill formula: C50 H96 N2 O10 CAS formula: C42 H74 O8. 2(C4 H11 N O)
IUPAC Name:
bis((2-hydroxyethyl)dimethylazanium) (4E)-3-{[2-({3-carboxylato-3-[(2E)-hexadec-2-en-2-yl]propanoyl}oxy)ethoxy]carbonyl}-4-methyloctadec-4-enoate
Constituent 2
Reference substance name:
BIS(DIMETHYL-(2-HYDROXYETHYL)AMMONIUM) 1,2-ETHANEDIYL-BIS (2-HEXADECENYLSUCCINATE)
IUPAC Name:
BIS(DIMETHYL-(2-HYDROXYETHYL)AMMONIUM) 1,2-ETHANEDIYL-BIS (2-HEXADECENYLSUCCINATE)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd
- Age at study initiation: 10 - 12 weeks
- Weight at study initiation: 2-5- 257 g
- Fasting period before study: None
- Housing: Suspended polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Free access
- Water (e.g. ad libitum): Free access
- Acclimation period: At least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 50 - 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light


IN-LIFE DATES: NDA

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: NDA
- % coverage: ca. 10% of total body surface area
- Type of wrap if used: HYPERTIE self adhesive bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treated skin and surrounding hair wiped with cotton wool moistened with arachis oil B.P.
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): N/A
- Constant volume or concentration used: yes
- For solids, paste formed: N/A


VEHICLE
- Amount(s) applied (volume or weight with unit): N/A (test material used as supplied - no vehicle)
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
2000 kg/kg: 5 male, 5 female
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations made 0.5, 1, 2 and 4 hours after dosing, and subsequently once daily for 14 days. Bodyweight measurements taken on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: None
Statistics:
Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test material was made.

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: No deaths occured and no signs of toxicity were observed.
Gross pathology:
Effects on organs:
No treatment-related macroscopic findings were observed.
Other findings:
Signs of toxicity (local):
No signs of toxicity were noted in male animals. Female rats had very slight to well-defined erythema on the treated areas upon removal of the patches; these effects persisted for 3 to 4 days. A crust formation was also evident for 1 animal at 3 and 4 days. There were no dermal effects apparent at 5 days post-dose.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of the test material, OS 114451A, in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

In an acute dermal toxicity study (525/033), a group of 10 10-12 week old Sprague-Dawley CD strain rats (five male and five female) were dermally exposed to neat OS 114451A for 24 hours toapproximately 10% of body surface area at a dose level of  2000  mg/kg bw.  Animals then were observed for 14 days.

 

Combined Dermal LD50= >2000 mg/kg bw

  

No mortality occurred. No signs of systemic toxicity were noted during the study, and no abnormalities were noted at necropsy. Some signs of irritation were noted in the female animals.