Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only available as a brief summary report

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A total of ten rats were administered the test material at several doses by stomach tube and assessed for toxic symptoms and weight gain.
GLP compliance:
not specified
Test type:
other: Range finding acute oral toxicity study
Limit test:
no

Test material

Constituent 1
Reference substance name:
Reaction mass of benzyl 1-(isobutyryloxy)-2,2,4-trimethylpentan-3-yl phthalate and benzyl 3-(isobutyryloxy)-2,2,4-trimethylpentyl phthalate
EC Number:
701-008-3
Molecular formula:
C27H34O6
IUPAC Name:
Reaction mass of benzyl 1-(isobutyryloxy)-2,2,4-trimethylpentan-3-yl phthalate and benzyl 3-(isobutyryloxy)-2,2,4-trimethylpentyl phthalate
Constituent 2
Chemical structure
Reference substance name:
Benzyl 3-isobutyryloxy-1-isopropyl-2,2-dimethylpropyl phthalate
EC Number:
240-920-1
EC Name:
Benzyl 3-isobutyryloxy-1-isopropyl-2,2-dimethylpropyl phthalate
Cas Number:
16883-83-3
Molecular formula:
C27H34O6
IUPAC Name:
Benzyl 2,2,4-trimethyl-1-[(2-methylpropanoyl)oxy]pentan-3-yl benzene-1,2-dicarboxylate
Details on test material:
- Name of test material (as cited in study report): Santicizer 278
- Lot/batch No.: EL 9026
no further data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 220-255 g
no further data


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2.0, 3.16, 5.01, 7.94, 12.6 and 15.8 g/kg bw
No. of animals per sex per dose:
1 female at each of 2.0, 5.01 and 12.6 g/kg bw, 1 male at each of 3.16 and 7.94 g/kg bw, and 2 females and 3 males at 15.8 g/kg bw.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 9 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic evaluation
Statistics:
No data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 800 mg/kg bw
Remarks on result:
other: No deaths seen at up to 15800 mg/kg bw
Mortality:
All rats survived, and were sacrificed nine days after dosing
Clinical signs:
Reduced appetite and slight weakness seen for one to three days (numbers of animals and doses not given)
Body weight:
Weight gain was "near normal", no further details given
Gross pathology:
At necropsy, two rats had haemorragic areas in the lungs, and all 6 rats receiving 12.6 g/kg bw and above had gaseous intestinal tracts. The viscera of animals receiving up to 7.84 g/kg bw appeared normal

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
No deaths were seen in ten rats (mixed sex) given a single administration of undiluted Santicizer 278 by stomach tube at up to 15.8 g/kg bw.
Executive summary:

Undiluted Santicizer 278 was administered to Sprague-Dawley rats (of either sex) by stomach tube at 2.0, 3.16, 5.01, 7.94 or 12.6 g/kg bw, and to 5 rats (3 male and 2 female) at 15.8 g/kg bw. The animals were assessed for toxic symptoms and weight gain during the observation period, and the surviving animals were sacrificed nine days after dosing and examined macroscopically.

 

All ten animals survived the nine day observation period. Reduced appetite and slight weakness were seen for one to three days (numbers of animals and doses not given), whilst weight gain was described as "near normal". At necropsy, two rats had haemorragic areas in the lungs, and all 6 rats receiving 12.6 g/kg bw and above had gaseous intestinal tracts. The viscera of animals receiving up to 7.84 g/kg bw appeared normal. The investigators concluded that “the compound was classed as practically non-toxic by oral ingestion in male and female rats”. Under the conditions of this study, the acute oral LD50 can be considered greater than 2 g/kg bw (but likely much higher). Under the EC CLP regulations, this study would indicate that Santicizer 278 is not classified for acute oral toxicity.