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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Remarks:
The study director, M. Lheritier, from Hazleton France, confirmed that the test was performed according to GLP rules.
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Molecular formula ; C18H30
Molecular weight : 240 g
Batch number : O E 241

Test animals

Species:
rat
Strain:
ICR
Sex:
male/female
Details on test animals and environmental conditions:
Young adults, 5 to 7 weeks old, housing in sex and in group of 2 (for the preliminary study) in group of 5 (for the main study) in polycarbonat cages, temperature ranging from 19 to 25°C, humidity 30 to 70 % R.H., lighting 12 hour light-dark cycle, fed ad libitum with rat-mouse pelleted complete maintenance diet, free access to softened and filtered drinking water

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Use of a curved oesophage probe in stainless steel
Doses:
Preliminary study : 3 groups of 2 males and 2 females each were treated with dose of 507, 1006 and 2004 mg/kg.
Main study : as there was no death at dose level of 2004 mg/kg during the preliminary treatment, a unique of 2004 mg/kg was administrated to 5 males and 5 females.
No. of animals per sex per dose:
Preliminary study : 3 groups of 2 males and 2 females per dose
Main study : 5 males and 5 females per dose
Control animals:
yes
Details on study design:
Main study : a single dose of the undiluted test material was administered to ten animals at a dose level of 2 004 mg/kg. A control group was included.
The animals were observed for signs of behavioral changes at the end of gavage and during the 14 following days. The weight change of the
tested animals was identical to that of the control group. All animals were euthanized at the conclusion of the observation period. Autopsies were performed on all animals (J15).

Results and discussion

Preliminary study:
The preliminary study at dose levels 507, 1006 and 2004 mg/kg did not show any effect on the tested animals.
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD0
Effect level:
> 2 004 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD0
Effect level:
> 2 004 mg/kg bw
Based on:
test mat.
Mortality:
None of the tested animals died.
Clinical signs:
No pathological clicical sign was observed
Body weight:
The weight change of the tested animals was identical to that of the control group during the 2 weeks following the test.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to this experiment the LD0 for linear dodecylbenzene is > 2004 mg/kg. As branching does not impact toxicity and to avoid unnecessary animal testing we considered that same result can be applied to our substance, C12 branched alkylbenzene.
Executive summary:

A single dose of the undiluted test material was administered to ten animals at a dose level of 2004 mg/kg. A control group was included. The animals were observed for signs of behavioral changes at the end of gavage and during the 14 following days. The weight change of the tested animals was identical to that of the control group. All animals were euthanized at the conclusion of the observation period. Autopsies were performed on all animals (J15). No treatment related gross postmortem findings were evident at necropsy.