Registration Dossier

Administrative data

Description of key information

LD50 . oral > 15600 mg/kg

FLL sample 4, limit test, LD50 oral > 2000 mg/kg

FLL sample 4, LD50, dermal > 2000 mg/kg

acute toxicity inhalation: not relevant

The more conservative 2000 mg/kg bw no effect levels from the more extensive read across studies was used as the starting point to derive DNELs for the sulfated fat liquors.

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:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Good study, no GLP compliance.
Qualifier:
according to guideline
Guideline:
other: 67/548/CEE
Deviations:
no
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Nossan Correzzana
- Weight at study initiation: 200 g
- Fasting period before study:last night before starting experiment, and 4 hours after dose administration
- Housing: 5 per cage in transparent polycarbonate cage 1290
- Diet: commercial pellet, ad libitum.
- Water: municipal filtered tap water,, ad libitum.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20±1
- Humidity (%):55±15
- Air changes (per hr):8
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
DOSAGE PREPARATION : 1.5 mg/100gr bw
Doses:
15600 mg/kg
No. of animals per sex per dose:
5 x sex x dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing:before treatment
- Necropsy of survivors performed: yes
- Other examinations performed: gastro-intestinal tract, Peripheral nervous system, central nervous system, urine analisys, cardiovascular, respiratory,
Statistics:
LD50 was calculated by Thompson-Weil method.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 15 600 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 600 mg/kg bw
Based on:
test mat.
Mortality:
no motality observed
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on result (LD50>15600 mg/kg bw) the test item castol oil is considered as non toxic substance.
Executive summary:

Castor oil sulphated sodium salt is administered by gavage on 10 wistar rats by method 67/548/ECC. Based on result (LD50>15600 mg/kg bw) the test item castol oil is considered as non toxic substance.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
15 600 mg/kg bw
Quality of whole database:
Quality of the database is not very high, but enough to assess acute toxicity of the substance

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
Clinical signs:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

The test performed in 1984 follows old guidelines but it is still representative of the substance toxicity. The other two studies submitted for acute oral toxicity, performed in 2010 in GLP, showed that this class of substance does not show any potential to be toxic after single exposure. Therefore, the test on the targte substance is considered valid and taken as key study. However for CAS calculations values of 2000 mg/kg are used, following a more conservative case.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are the following:

For oral exposure:

Category 1: ATE <= 5 mg/kg bw

Category 2: 5 < ATE <= 50 mg/kg bw

Category 3: 50 < ATE <= 300 mg/kg bw

Category 4: 300 < ATE <= 2000 mg/kg bw

For pure substance ATE can be estimated to be similar to LD50 that can be used for classification.

The LD50, oral of the test substance was determined to be > 2000 mg/kg bw and therefore, the test substance is not classified for Acute toxicity by oral exposure.

For dermal exposure:

Category 1: ATE <= 50 mg/kg bw

Category 2: 50 < ATE <= 200 mg/kg bw

Category 3: 200 < ATE <= 1000 mg/kg bw

Category 4: 1000 < ATE <= 2000 mg/kg bw

The LD50, dermal of the test substance was determined to be > 2000 mg/kg bw and therefore, the test substance is not classified for Acute toxicity by dermal exposure.