Castor oil, sulfated, ammonium salt

Endpoint summary

Description of key information

analogue substance 1 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

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

other: read across from analogue substance

Adequacy of study:

supporting study

Study period:

From 21 April 2010 - 01 June 2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Read across from a GLP Guideline Study (OECD 420, EC B.1 bis)

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Bicester, Oxon, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 173 - 178 g
- Fasting period before study: overnight before dosing, and approximately 3-4 hours after dosing
- Housing: housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodchips
- Diet (e.g. ad libitum): ad libitium access to 2014 Teklad Global Rodent diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 degrees C
- Humidity (%): 30- 70 percent
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

IN-LIFE DATES: Not reported

Route of administration:

oral: gavage

Vehicle:

arachis oil

Remarks:

(BP)

Details on oral exposure:

VEHICLE: no details reported

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

DOSAGE PREPARATION (if unusual): suspension of test item in distilled water

CLASS METHOD: not applicable
VEHICLE
- other: arachis oil BP was used for the 300 mg/kg dose level, no vehicle was used for the 2000 mg/kg dose level

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

DOSAGE PREPARATION (if unusual): not applicable

CLASS METHOD: not applicable

Doses:

300, 2000 mg/kg

No. of animals per sex per dose:

1 animal at 300 mg/kg, 5 animals at 2000 mg/kg

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations, weighed at days 0, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy (external examination and opening of abdominal and thoracic cavities to look for macroscopic abnormalities)

Statistics:

None reported

Preliminary study:

One animal was treated with 300 mg/kg bw test material suspended in Arachis oil BP and observed for 14 days. The animal exhibited no mortality, no signs of cystemic toxicity, expected gains in bodyweight, no abnormalities at necropsy.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no effects were observed at the highest dose tested, 2000 mg/kg bw

Mortality:

No deaths observed

Clinical signs:

other: No signs of systemic toxicity were noted

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

Not applicable

Table 5. Individual bodyweights and bodyweight changes.

Dose level, mg/kg	Animal number and sex	Bodyweight (g) at Day			Bodyweight gain (g) during week
		0	7	14	1	2
2000	2-0 Female	169	181	193	12	12
	3-0 Female	176	189	199	13	10
	3-1 Female	170	186	199	16	13
	3-2 Female	194	210	230	16	20
	3-3 Female	176	200	216	24	16

 

Interpretation of results:

not classified

Remarks:

Migrated information according to CLP Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight

Executive summary:

Introduction. The study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat. The method was designed to meet the requirements of the following:

- OECD Guideline for Testing of Chemicals No 420 “Acute oral toxicity – fixed dose method” (adopted 17 December 2001)

- Method B1 bis Acute toxicity (oral) of Commission Regulation (EC) No. 440/2008

 

Method. Following a sighting test at dose levels of 300 and 2000 mg/kg, a further group of four fasted female animals were given a single oral dose of undilted test material at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

 

Morality. There were no deaths.

 

Clinical Observations. There were no signs of systemic toxicity ntoed.

 

Bodyweight. All animals showed expected gains in bodyweight.

 

Necropsy. No abnormalities were noted at necropsy.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

other: read across from analogue substance

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:

administered volume : 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 mortality observed

Clinical signs:

other: 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 analogue substancel is considered as non toxic substance.

Executive summary:

Analogue substance 1 is administered by gavage on 10 wistar rats by method 67/548/ECC. Under the experimental conditions the substance showed a LD50>15600 mg/kg

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 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

other:

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:

other: read across from analogue substance

Adequacy of study:

weight of evidence

Study period:

2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Read across from a well performed GLP study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: HsdRccHan(TM)WIST

Sex:

male/female

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

Doses:

2000 mg/Kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

males: 0/5
females: 0/5

Interpretation of results:

not classified

Remarks:

Migrated information Accordinf to CLP Criteria used for interpretation of results: EU

Conclusions:

The dermal median lethal dose was > 2000 mg/kg for acute (24-hour) exposure for rat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

For read across puposes the more representative substance is analogue substance 1 for assessing acute oral toxicity. 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 potentil to be toxic after single exposure. Therefore, the test on analogue substance 1 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.