Registration Dossier

Diss Factsheets

Administrative data

Description of key information

The registration substance is of no significant toxicity for oral and dermal routes. The acute inhalation toxicity is of no relevance for the risk assessment.

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:
1972-1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
acute oral toxicity after single application
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst
- Age at study initiation: no data
- Weight at study initiation: 82-104 g (mean 93 g )
- Fasting period before study: 16 h
- Housing: in plastic cages
- Diet (e.g. ad libitum): Standard Altromin R, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS: no data
Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 %
- Amount of vehicle (if gavage): dependent on dose, not constant
- Justification for choice of vehicle: not given

MAXIMUM DOSE VOLUME APPLIED: 50 ml/kg

Doses:
800 mg/kg
1250 mg/kg
2000 mg/kg
3200 mg/kg
5000 mg/kg
No. of animals per sex per dose:
10 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing once per week
- Necropsy of survivors performed: unclear from report
- Other examinations performed: body weight, no further information
Statistics:
LD50 was calculated using Probit analysis
Preliminary study:
No sex differences were observed in preliminary study, therefore only females were used in the main study
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
3 190 mg/kg bw
Mortality:
The following number of deaths were observed per dose group:
dose (mg/kg) -- number of death animals -- number of total animals
800 -- 0 -- 10
1250 -- 0 -- 10
2000 -- 1 -- 10
3200 -- 5 -- 10
5000 -- 10 -- 10
Clinical signs:
not reported
Body weight:
body weights are reported but results were not analysed or commented
Gross pathology:
unclear if done
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of 3190 mg/kg was obtained for the registration substance.
Executive summary:

The registration substance was given to female rats (n = 10 per dose) via gavage at doses of 800, 1250, 2000, 3200 and 5000 mg/kg. No death occured at 800 and 1250 mg/kg. One, five and ten rats died at 2000, 3200 and 5000 mg/kg respectively. The LD50 of 3190 mg/kg was obtained.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 190 mg/kg bw
Quality of whole database:
One reliable experimental data

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
exposure considerations
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
Justification for type of information:
Acute inhalation toxicity
With respect to the risk assessment of the use of the registration substance, the endpoint acute toxicity via inhalation is of no relevance:
a) The registration substance is solid at room temperature. Upon heating it undergoes decomposition at 220-240 °C without melting. The vapor pressure is very low (7.0 x 10-5 Pa at 20°C, calculated). Exposure to gaseous form is of no relevance.
b) The registration substance is manufactured in entirely closed system and the formulation occurs under industrial setting. No significant exposure of workers to airborne particles can be reliably derived. Further, the registration substance is corrosive to eye, indicating corrosivity to mucosal tissues. It is likely that the workers exposed accidentally to the airborne particles would immediately take actions to stop the exposure.
c) The registration substance is used solely as cosmetic ingredient for fluid products to be used dermally for the consumers. No spray application is known for the registrant. For the consumer safety the inhalation route is of no relevance.
With respect to the inhalation exposure no concern can be reliably derived for the risk assessment for workers and consumers.
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
Justification for type of information:
Acute dermal toxicity
No concern with respect to the acute dermal toxicity can be reliably derived based on the following experimental data:
a)The dermal penetration was investigated according to guideline OECD 428 ( Skin Adsorption; In Vitro method). When 3% formulation of behenyl trimethyl ammonium chloride (major component of the registration substance) was applied for 24 h on human skin the mean total absorption was 0.16+/-0.08%.
b)The acute oral toxicity was investigated by treatment of animals at doses of 800, 1250, 2000, 3200 and 5000 mg/kg. No death occurred at 800 and 1250 mg/kg. One, five and ten rats died at 2000, 3200 and 5000 mg/kg respectively. The LD50 of 3190 mg/kg was obtained.
The internal systemic burden upon dermal exposure will be apparently very low. In combination of low acute oral toxicity, no significant effect upon acute dermal exposure can be reasonably derived.
No classification is warranted for the endpoint acute dermal toxicity and no animal testing is recommended.
Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
The acute dermal toxicity assessed based on the experimental data on skin penetration and on acute oral toxicity

Additional information

Justification for classification or non-classification

No classification with respect to the acute toxicity is warranted for the registration substance accordingto the criteria of the EU Classification Labeling and Packaging Regulation (1272/2008/EC).

No concern for the oral route was derived based on the experimental data and no concern for the dermal route was derived based on the skin penetration and acute oral toxicity data. No significant risk was derived for the inhalation route based on the expected low exposure level for workers and consumers.