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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data migrated from NONS with permission to refer granted by ECHA.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EEC
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2-diacetoxybut-3-ene
EC Number:
421-720-5
EC Name:
1,2-diacetoxybut-3-ene
Cas Number:
18085-02-4
Molecular formula:
C8H12O4
IUPAC Name:
1-(acetyloxy)but-3-en-2-yl acetate
Test material form:
liquid
Details on test material:
No information on test material available. Endpoint study information provided by ECHA from migrated NONS data and specific information not included.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Duration of treatment / exposure:
28 days
Frequency of treatment:
7 days per week
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
75 mg/kg bw/day (nominal)
Dose / conc.:
225 mg/kg bw/day (nominal)
Dose / conc.:
750 mg/kg bw/day (nominal)
No. of animals per sex per dose:
5 male and female animals at each dose group
Control animals:
yes, concurrent vehicle

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Decreased faeces were observed in all rats that received 750 mg/kg/day and sialorrhea was observed in all treatment groups.
Mortality:
mortality observed, treatment-related
Description (incidence):
In animals that received 750 mg/kg/day 1 male was found dead on Day 3 and 1 male was sacrificed as moribund on Day 11.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
In males that received 750 mg/kg/day, mean bodyweights were significantly lower than in controls.
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
effects observed, treatment-related
Description (incidence and severity):
Food consumption for males that received 750 mg/kg/day was reduced on Days 4 and 7.
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
Alkaline phosphatase (ALP) and ALAT concentrations were increase in males that received 750 mg/kg/day. A slight, statistically significant increase in ALAT was also observed in males that received 225 mg/kg/day. The slight increases in ALAT and ALP could be related to the changes observed in the pancreas of animals that received 750 mg/kg/day.
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
In males that received 750 mg/kg/day, there were increases in relative adrenal, testes, kidney and liver weights and decreased absolute spleen, kidney and thymus weights. Liver weights were also increased in females that received 750 mg/kg/day. No associated gross or microscopic findings were observed in these organs.
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
effects observed, non-treatment-related
Description (incidence and severity):
Mild exocrine cell necrosis of the pancreas was observed in animals that received 750 mg/kgbw.
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
225 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
not specified
Basis for effect level:
histopathology: non-neoplastic
Dose descriptor:
NOEL
Effect level:
< 75 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
not specified
Basis for effect level:
other: Lack of toxicologically significant effects

Target system / organ toxicity

Critical effects observed:
yes
Lowest effective dose / conc.:
750 mg/kg bw/day (nominal)
System:
other: Pancreas
Organ:
pancreas
Treatment related:
yes
Dose response relationship:
no
Relevant for humans:
not specified

Applicant's summary and conclusion

Conclusions:
Based on information provided by ECHA, the results of a 28 day repeated dose study include a NOAEL of 225 mg/kg/day based on effects observed in the pancreas of high dose animals.