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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The oral LD50 of a stereoisomer of 2-Propenal, 3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-methyl-, (E)- was determined to be >2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP similar to guideline study, available as unpublished report, limitations in design and/or reporting buth otherwise adequate for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Five Wistar rats per sex per dose were exposed via oral gavage. After an exposure period of 14 days, in which documentation on clinical signs was performed, all animals were necropsied.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K.Thomae GmbH. D-7950 Biberach, FRG
- Weight at study initiation: mean 172 and 176 g, for males and females respectively
- Fasting period before study: 16 h
- Housing: 5 animals per cage, stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: ad libitum, Kliba-Labordiaet 343 (Klingentalmuehle AG CH-4303 Kaiseraugst, Switzerland)
- Water: ad libitum, tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air: air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40 g/ 100 mL (w/v)
- Amount of vehicle (if gavage): 5 mL/kg
- Justification for choice of vehicle: test substance is insoluble in water
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: at day 0, 7 and 13
- Frequency of observations: Signs and symptoms several times on the day of administration, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.S
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed in all exposed animals.
Clinical signs:
other: Diarrhea was observed 4 hours after exposure in male and female rats
Gross pathology:
No pathologic findings were noted in sacrificed animals.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
Under the conditions of this test, the LD50 was determined to be >2000 mg/kg bw.
Executive summary:

In an oral acute toxicity study performed similar to OECD 401, five Wistar rats per sex were exposed to 2000 mg/kg bw of the test substance dissolved in olive oil via oral gavage. After an observation period of 14 days the surviving animals were necropsied. Diarrhea was observed 4 hours after exposure. No mortality was observed. No pathologic findings were noted in sacrificed animals. The LD50 was determined to be > 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No studies on acute oral toxicity of 2-Propenal, 3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-methyl-, (E)- were available. However, Article 13 of REACH states that, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests, i.e. applying alternative methods such as in vitro tests, QSARs, grouping and read-across. One acute oral toxicity study with a stereoisomer of 2-Propenal, 3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-methyl-, (E)- is available.

In an oral acute toxicity study performed similar to OECD 401, five Wistar rats per sex were exposed to 2000 mg/kg bw of 2-Propenal, 3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-methyl-, dissolved in olive oil via oral gavage (BASF 1989). After an observation period of 14 days the surviving animals were necropsied. Diarrhea was observed 4 hours after exposure. No mortality was observed. No pathologic findings were noted in sacrificed animals. The LD50 was determined to be > 2000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
One acute oral toxicity study performed with a steroisomer of 2-Propenal, 3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-methyl-, (E)- is available.

Justification for classification or non-classification

Because an oral LD50 of >2000 mg/kg bw for a stereoisomer of 2-Propenal, 3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-methyl-, (E)- was determined it is expected that 2-Propenal, 3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-methyl-, (E)- will have a high LD50 for oral toxicity. Based on this classification for acute oral toxicity is not warranted in accordance with EU Directive 67/548 (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.