Registration Dossier

Administrative data

Description of key information

Acute toxicity oral: There is a GLP study according to OECD 401 done with a similar subtance (C12 linear alkylbenzene). Other data on rat acute oral toxicity of LAB in C9 -C24 have been reported in ECB (1997) adn OECD (2002) dossiers: LD50 values were >=17000 mg/Kg for the analogues Alkylate 215 and Alkylate 225.

Acute inhalation toxicity: No study available for the substance. Data on aerosols of LAB C9 -C14 have been reported in

ECB (1997) adn OECD (2002) dossiers: LC50 values were > 1.82 mg/L for the analogue Alkylate 215. Based on the low vapour pressure of the substance it is not expected that there is acute exposure to the substance.

Acute dermal toxicity: a large number of studies on LAB have all resulted in rat and rabbit acute dermal LD50 values above 2000 mg/kg and sometimes up to and above 10 g/kg.


Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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).
Preliminary study:
The preliminary study at dose levels 507, 1006 and 2004 mg/kg did not show any effect on the tested animals.
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 004 mg/kg bw
Quality of whole database:
study on a similar substance, according to OECD 401, GLP

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
ICR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazleton Les Oncins
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 5-7 weeks
- Housing: polycarbonate cages 305*180*184 mm
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3ºC
- Humidity (%): 30-70% RH
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 7:30-19:30

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
2004 mg/kg (2.33 ml/kg)
No. of animals per sex per dose:
preliminary study: 4 males/ 4 females
full study: 10 males / 10 females
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 004 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
no
Body weight:
no variation
Gross pathology:
not observed effects
Interpretation of results:
GHS criteria not met
Conclusions:
In this study a LD0 >=2004 mg/kg bw was observed (no mortalities)
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
10 000 mg/kg bw

Additional information

Justification for classification or non-classification

Based on the available data and when compared with classification cut-offs of the Regulation 1272/2008 (CLP), the substance is not classified for acute toxicity by oral, dermal and inhalative routes. No severe adverse effects are reported for single exposures and the LD50 or LC50 values are extremely high (when tested above regulatory doses), therefore the STOT SE classification is not proposed either.