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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
study report 29- OCT-1976 - no additional details
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
prior to GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2-hydroxymethyl butane
EC Number:
701-135-4
Cas Number:
30499-70-8
Molecular formula:
C15H26O6;C15H22O5
IUPAC Name:
Reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2-hydroxymethyl butane
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
other: Tif RAIf (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
Healthy random bred rats of the Tif RAif (SPF) strain raised on our premises were used for these experiments.
They were kept at a room temperature of 22 +/- 1° C, at a relative humidity of 55 +/- 5 % and on a 14 hours light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted for a minimum of 4 days and the initial body weight ranged from 160 to 180 grams.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2%
Details on oral exposure:
Animals fasted overnight were treated by oral intubation.
Doses:
775, 1000, 2150, 3170, 4640, 7750 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages (type 3) .
Animals fasted overnight were treated by oral intubation. Physical condition and rate of deaths were monitored throughout the whole observation
period.
Statistics:
LD 50 including 95 % confidence limits were calculated by the probit analysis method (Goulden A., Methods of Statistical Analysis, John Wiley and Sons, 1960, 3rd printing, pages 404-408).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 398 mg/kg bw
Based on:
test mat.
95% CL:
2 812 - 4 108
Mortality:
5 males and 5 females per dose group
1 hour: no deaths

24 hours: no deaths at 775 and 1000 mg/kg; 1 female at 2150 mg/kg; 2 males and 3 females at 3170 mg/kg; 2 males and 3 females at 4640 mg/kg; 5 males and 5 females at 7750 mg/kg

48 hours: no deaths at 775 and 1000 mg/kg ; 1 female at 2150 mg/kg; 2 males and 3 females at 3170 mg/kg; 2 males and 4 females at 4640 mg/kg; 5 males and 5 females at 7750 mg/kg

7 and 14 days: no deaths at 775 and 1000 mg/kg ; 1 female at 2150 mg/kg; 2 males and 3 females at 3170 mg/kg; 3 males and 4 females at 4640 mg/kg; 5 males and 5 females at 7750 mg/kg
Clinical signs:
other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. Additionally in the highest dosage group convulsions and trismus were also observed. The surviving animals recovered wit
Gross pathology:
They were submitted to a necropsy whenever they died, survivors at the end of the observation period. No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The acute oral LD50 of the test material in rats of both sexes observed over a period of 14 days is 3398 (2812-4108) mg/kg*.
Executive summary:

Healthy random bred rats of the Tif RAif (SPF) strain were tested for acute oral toxicty of the test material..

Animals were fasted overnight and treated by oral intubation. Physical condition and rate of deaths were monitored throughout the whole observation period. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. Additionally in the highest dosage group convulsions and trismus were also observed. The surviving animals recovered within 7 to 12 days.

The acute oral LD50 of the test material in rats of both sexes observed over a period of 14 days was demonstrated to be 3398 (2812-4108) mg/kg bw.