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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 December 2016 - 03 January 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The study was performed as a data requirement for a registration in China.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
August 1998
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: JMAFF Guidelines
Version / remarks:
November 2000, including the most recent revisions
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
d.d. 3 November 2015
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
420-990-1
EC Name:
-
Cas Number:
146421-65-0
Molecular formula:
C20H36N2O6
IUPAC Name:
4-(ethenyloxy)butyl N-[6-({[4-(ethenyloxy)butoxy]carbonyl}amino)hexyl]carbamate
Constituent 2
Chemical structure
Reference substance name:
4-(ethenyloxy)butyl N-{6-[({[6-({[6-({[4-(ethenyloxy)butoxy]carbonyl}amino)hexyl]carbamoyl}oxy)hexyl]oxy}carbonyl)amino]hexyl}carbamate
Cas Number:
1516571-16-6
Molecular formula:
C34H62N4O10
IUPAC Name:
4-(ethenyloxy)butyl N-{6-[({[6-({[6-({[4-(ethenyloxy)butoxy]carbonyl}amino)hexyl]carbamoyl}oxy)hexyl]oxy}carbonyl)amino]hexyl}carbamate
Test material form:
solid: flakes
Details on test material:
Appearance: White Flakes
Test item storage: At room temperature
Specific details on test material used for the study:
Adjustment was made for specific gravity (1.036) of the vehicle.

In order to obtain homogeneity, the test item (formulations) were heated in a water bath with a maximum temperature of 76.1ºC for a maximum of 38 minutes. The test item (formulations) were allowed to cool to a temperature of maximally 40ºC prior to dosing.

The test item preparations were stirred on a magnetic stirrer during application.

Test animals

Species:
rat
Strain:
other: Crl: WI(Han)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant:yes
- Age at study initiation: approx. 10 weeks old
- Weight at study initiation: Males: 258 - 295 g, Females: 191 - 216 g.
- Housing: During the acclimatization period the animals were group housed in Makrolon cages (MIV type, height 18 cm) containing sterilized sawdust as bedding material and paper as cage-enrichment. During the study the animals were individually housed in Makrolon cages (MIII type, height 18 cm.).
- Diet: Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 18 - 24
- Humidity (%): 40 - 70
- Air changes (per hr): >= 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
propylene glycol
Remarks:
Specific gravity: 1.036
Details on dermal exposure:
TEST SITE
- Area of exposure: 18 cm^2 for females, 25 cm^2 for males
- % coverage: approx. 10% of the total body surface
- Type of wrap if used: a surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.

REMOVAL OF TEST SUBSTANCE
- Washing: tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 5000 mg/kg bodyweight
- Constant volume or concentration used: yes, 20 mL/kg bodyweight
Duration of exposure:
24 hours
Doses:
5000 mg/kg bodyweight
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations:
- Mortality: twice daily
- Clinical observations: at periodic intervals on the day of dosing and once daily thereafter.
- Body weights: on day 1 (pre-administration), day 8 and day 15.
- Necropsy of survivors performed: yes


Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
No mortality occurred.
Clinical signs:
other: Red nose was noted for three males and four females on day 2 only.
Gross pathology:
No abnormalities were seen at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of an acute dermal study (limit study), performed according to OECD/EC guidelines and GLP principles, The dermal LD50 value of URALAC P 1920C in Wistar rats was determined to exceed 5000 mg/kg body weight. As a consequence, URALAC P 1920C is not classified according to GHS and CLP criteria.
Executive summary:

An acute dermal study (limit study) was performed according to OECD/EC guidelines and GLP principles. Five male and five female rats were exposed to 5000 mg/kg bw and observed for 14 days. No mortality occurred. A red nose was noted for three males and four females on day 2 only. No unexpected changes in body weight gain occurred, no abnormalities were seen at necropsy. These reuslts demonstrate that the dermal LD50 value of URALAC P 1920C in Wistar rats exceeds 5000 mg/kg body weight. As a consequence, URALAC P 1920C is not classified according to GHS and CLP criteria.