[No public or meaningful name is available]

Endpoint summary

Description of key information

Acute Oral Toxicity: 

Target: Reaction mass of (4RS,4aRS,8RS,8aRS)-4-ethyl-8,8a-dimethyloctahydro-1(2H)-naphthalenone and (±)-(4RS,4aSR,8SR,8aSR)-4-ethyl-8,8a-dimethyloctahydro-1(2H)-naphthalenone and (±)-(4RS,4aSR,8RS,8aSR)-4-ethyl-8,8a-dimethyloctahydro-1(2H)-naphthalenone: LD50 >2000 mg/kg bw, 2021.

Read-across: source data: Reaction mass of (4RS,4aRS,8RS,8aRS)-4-ethyl-8-methyloctahydronaphthalen-1(2H)-one and (4RS,4aSR,8SR,8aRS)-4-ethyl-8-methyloctahydronaphthalen-1(2H)-one and (4RS,4aSR,8SR,8aSR)-4-ethyl-8-methyloctahydronaphthalen-1(2H)-one: Measured LD50 > 2000 mg/kg bw in female Wistar rats. Assessed LD50 cut-off value was considered to be 2500 mg/kg bw, OECD TG 423, 2013. 

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:

23-08-2013 to 17-09-2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study performed under GLP. All relevant validity criteria were met.

Justification for type of information:

Information as to the availability of the in vivo study is provided in 'attached justification'.

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

inspected: March 2013 ; signature: May 2013

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI (Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Recognised animal supplier
- Females (if applicable) nulliparous and non-pregnant: Yes.
- Age at study initiation: ca. 8 weeks (nulliparous and non-pregnant)
- Weight at study initiation: 146 - 168 g; Body weight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: Overnight and until 3-4 hours after administration of the test item.
- Housing: Group housing of 3 animals per cage containing sterilized sawdust as bedding material and paper as cage-enrichment.
- Water: ad libitum
- Acclimation period: At least five (5) days under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0
- Humidity (%): 40 to 70 (Deviations from the maximum level of daily mean relative humidity occurred. Laboratory historical data do not indicate an effect attributable to the deviations).
- Air changes (per hr): typically, at least 15
- Photoperiod (hrs dark / hrs light): 12 hours light/dark

IN-LIFE DATES: 23-08-2013 to 17-09-2013

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Identity: Not applicable.
- Concentration in vehicle: Not applicable. Unchanged (no vehicle).
- Amount of vehicle (if gavage): Not applicable.
- Justification for choice of vehicle: Not applicable.

MAXIMUM DOSE VOLUME APPLIED: 2.06 mL/kg bw

DOSAGE PREPARATION (if unusual): Not applicable.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data suggesting the test material was toxic, 2000 mg/kg was chosen as the starting dose. The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups.

Doses:

2000 mg/kg

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Mortality/Viability: Twice daily; Bodyweights: Days 1 (pre-administration), 8 and 15; Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. The signs were graded according to fixed scales and the time of onset, degree and duration were recorded.
- Necropsy of survivors performed: yes

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

2000 mg/kg bw: Female number 5, was sarificed in moribund condition for humane reasons on day 2. No further mortality.

Clinical signs:

other: 2000 mg/kg bw: Clinical signs noted among the survivors between Days 1 and 3 included lethargy, hunched posture, uncoordinated movements, slow breathing, shallow respiration, piloerection, salivation, watery discharge from both eyes, and/or hypothermia. T

Gross pathology:

No abnormalities were found at macroscopic post mortem examination.

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the oral LD50 was established to be > 2000 mg/kg bw in female Wistar rats. According to OECD TG 423 the LD50 cut-off value was considered to be 2500 mg/kg bw.

Executive summary:

The study was performed according to OECD TG 423 and EU Method B1 tris Acute Toxicity, US EPA OPPTS 870.1100 and Japanese JMAFF guidelines and in accordance with GLP to assess the acute oral toxicity of the test item following a single oral administration in the female Wistar strain rat by the acute class method. The test item was administered by oral gavage in a PEG 400 vehicle to two sequential groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). There was two mortalities in the second group. Lethargy, flat and/or hunched posture, piloerection, slow breathing, uncoordinated movements, dark eye and/or watery discharge from the eyes were noted in all animals between Days 1 and 6. In addition one animal showed scales and scabs on the snout during the observation period. A second dose level was then employed at 300 mg/kg bodyweight. All animals showed hunched posture and one animal showed piloerection on Day 1. No further effects were subsequently seen. The body weight gain shown by survivors over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals at any dose level. The oral LD50 value of the test substance in Wistar rats was established to be > 300 and < 2000 mg/kg body weight. According to the OECD TG 423 test guideline, the LD50 cut-off value was considered to be 2500 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

The available information as a whole meets the tonnage driven information of REACH.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

The available information as whole meets the tonnage driven information requirements of REACH.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

The available information as a whole meets the tonnage driven information requirements of REACH.

Additional information

ORAL:

Key Study: OECD 423, 2014: Read-across SOURCE (Reaction mass of (4RS,4aRS,8RS,8aRS)-4-ethyl-8-methyloctahydronaphthalen-1(2H)-one and (4RS,4aSR,8SR,8aRS)-4-ethyl-8-methyloctahydronaphthalen-1(2H)-one and (4RS,4aSR,8SR,8aSR)-4-ethyl-8-methyloctahydronaphthalen-1(2H)-one):

The study was performed according to OECD TG 423 and EU Method B1 tris Acute Toxicity, US EPA OPPTS 870.1100 and Japanese JMAFF guidelines and in accordance with GLP to assess the acute oral toxicity of the test item following a single oral administration in the female Wistar strain rat by the acute class method. The test item was administered by oral gavage in a PEG 400 vehicle to two sequential groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). There was two mortalities in the second group. Lethargy, flat and/or hunched posture, piloerection, slow breathing, uncoordinated movements, dark eye and/or watery discharge from the eyes were noted in all animals between Days 1 and 6. In addition one animal showed scales and scabs on the snout during the observation period. A second dose level was then employed at 300 mg/kg bodyweight. All animals showed hunched posture and one animal showed piloerection on Day 1. No further effects were subsequently seen. The body weight gain shown by survivors over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals at any dose level. The oral LD50 value of the test substance in Wistar rats was established to be > 300 and < 2000 mg/kg body weight. According to the OECD TG 423 test guideline, the LD50 cut-off value was considered to be 2500 mg/kg body weight.

 

DERMAL: No data available on the substance. 

INHALATION: No data available on the substance. Read-across to EC 939-4003 for classification purpose only.  

Justification for classification or non-classification

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for acute toxicity: oral.