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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed in accordance with generally accepted scientific principles, possibly with incomplete reporting which do not affect the quality of the relevant results.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
Study pre-dates GLP
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Test substance name: ADOXAL
appearance: colorless liquid
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adults (Source: Charkes River (UK) Limited, Margate, Kent)
- Weight at study initiation: 165-205 g
- Fasting period before study: over night prior to dosing.
- Housing: In groups by sex, in polypropylene breeding cages.
- Diet/water: Oxoid maintenance diet supllied by Herbert C. Styles (Bewdley) Limited and water were provided ad libitum


ENVIRONMENTAL CONDITIONS
- The cages were places in a thermostatically controlled room under controlled lighting conditions.
Route of administration:
oral: gavage
Vehicle:
vegetable oil
Details on oral exposure:
DOSAGE PREPARATION
For all the dose levels the test material was suspended in vegetable oil on a v/v basis so that the required dose per kilogram was contained in 10 mL.
Doses:
Range finding test: dose levels of 5.0, 2.0, 1.0 and 0.5 mL/kg bw.
Definitive limit test: highest dose level.5.0 mL/kg bw
No. of animals per sex per dose:
Range finding test: groups of two rats (one male and one female)
Definitive limit test: groups of ten rats (five male and five female)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were weighed immediately prior to dosing. Animals were examined for overt signs of toxicity immediately after dosing, 4 hours after dosing and then on a daily basis for 14 days.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Mortality:
No mortalities were observed in either the range finding or the main study within the 14 day observation period.
Clinical signs:
other: No overt signs of toxicity were observed in either the range finding or the main study within the 14 day observation period.

Table 1: Results

Dose Level

(mL/kg bw)

No. of Rats

Sex

Bodyweight

Volume Dosed

Mortality

0-8 hours

1-7 hours

8-14 hours

Total

5.0

1

Male

180

1.80

0

0

0

0

0

1

Female

170

1.70

0

0

0

0

2.0

1

Male

170

1.70

0

0

0

0

0

1

Female

170

1.70

0

0

0

0

1.0

1

Male

205

2.05

0

0

0

0

0

1

Female

180

1.80

0

0

0

0

0.5

1

Male

195

1.95

0

0

0

0

0

1

Female

170

1.70

0

0

0

0

5.0

5

Male

190

1.90

0

0

0

0

0

5

Female

175

1.75

0

0

0

0

 

Interpretation of results:
GHS criteria not met
Remarks:
Not sufficient to be classified under the GHS criteria
Conclusions:
Under the conditions of the test, there were no mortalities observed among any of the animals dosed in this study. Furthermore no overt signs of toxicity were recorded during the 14 day observation period. Based on these observations it was concluded that the LD50 for the test material was greater than 5 mL/kg bw.
Executive summary:

In the key study Givaudan (1978), the acute oral toxicity of the test material was determined in a study where groups of two adult rats (one male and one female) were dose at levels of 5.0, 2.0, 1.0 and 0.5 mL/kg bodyweight in a range-finding study. Based on the results a further group of ten rats (five male and five female) was treated at the highest dose level. Animals were observed for mortality and overt signs of toxicity over a 14 day observation period. The methodology used was similar to that detailed in the OECD 401 guideline. The study pre-dates GLP.

Under the conditions of the test, there were no mortalities observed among any of the animals dosed in this study. Furthermore no overt signs of toxicity were recorded during the 14 day observation period. Therefore based on these observations it was concluded that the LD50 for the test material was greater than 5 mL/kg bw.

 

This study was performed in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results. The study was performed to a good standard however some limitations were present in the level of detail in the reporting of the methods and so was assigned a reliability score of 2 (reliable with restrictions), in accordance with Klimisch (1997) and considered suitable to fulfil the data requirement.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion