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Description of key information

The oral LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

 

Not scientifically necessary to conduct in vivo acute dermal or acute inhalation studies.

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:
30 April 2018 to 10 September 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
- Purity test date: UVCB; solid matter 41.4%
Species:
rat
Strain:
Wistar
Remarks:
Crl: WI(Han)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: ~8 to 11 weeks old
- Weight at study initiation: 149 to 183 g.
- Fasting period before study: yes
- Housing: On arrival and following assignment to the study, animals were group housed (up to 3 animals of the same sex and same dosing group together) in cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before the commencement of dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 22°C
- Humidity (%): 41 to 72%
- Air changes (per hr): Ten or greater air changes per hour
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
DOSAGE PREPARATION (if unusual): Adjustment was made for specific gravity of the test item. A correction was made for the purity/composition of the test item based on % solid matter (41.4%).

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The dose levels were based on the OECD test guidelines and were selected from the series 5 (lowest dose level), 50, 300 and 2000 (highest dose level) mg/kg body weight. The starting dose level should be the one that is likely to produce mortality in at least some of the animals and was selected based on available toxicity data of the test item.
Doses:
The first group was treated at an intended dose level of 2000 mg/kg. Based on the results, one additional group was dosed at an intended dose level of 2000 mg/kg. Based on
the correction factor calculated after the animals were dosed the actual given dose was 828 mg/kg. Based on this dose level, two additional groups were dosed at an actual dose of 2000 mg/kg to fulfill the dose level requirements of the guidelines.
No. of animals per sex per dose:
3 females/dose
Control animals:
no
Remarks:
Not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: General health/mortality and moribundity were observed twice daily. Postdose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter. Animals were weighed weekly.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: All animals assigned to the study were subjected to necropsy.
Statistics:
No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).
Preliminary study:
Not applicable
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 value of 1-Octanol, reaction products with phosphorus oxide (P2O5), potassium salts in Wistar rats was established to exceed 2000 mg/kg body weight.

According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.
Executive summary:

The acute oral toxicity of 1-Octanol, reaction products with phosphorus oxide (P2O5), potassium salts was assessed in Wistar rats according to OECD 423. The test substance was administered by oral gavage to two consecutive groups of three female Wistar rats at an intended dose level of 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).

 

No mortality occurred and the mean body weight gain shown by the animals 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.

 

The oral LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

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:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Annex VIII 8.5 indicates that in addition to the oral route, the information shall be provided for at least one other route (dermal or inhalation). The choice for the second route will depend on the nature of the substance and the likely route of human exposure. The dermal route is the appropriate second route as inhalation is unlikely due to the vapour pressure of ≤ 0.0000858 Pa at 20 °C. Skin contact during use as a textile fiber lubricant/finish is likely and the absorption through the skin is anticipated to be identical to the oral or inhalation routes of exposure. Information has been presented for both acute oral and dermal toxicity. Additionally, the toxicokinetics assessment indicates that exposure via oral, dermal or inhalation will result in comparable adsorption, distribution, metabolism, and excretion. Therefore, further testing of the acute inhalation toxicity is not scientifically necessary as the available toxicity studies adequately represent the toxicity profile of the registered substance.Annex VIII 8.5 indicates that in addition to the oral route, the information shall be provided for at least one other route (dermal or inhalation). The choice for the second route will depend on the nature of the substance and the likely route of human exposure. The dermal route is the appropriate second route as inhalation is unlikely due to the vapour pressure of ≤ 0.0000858 Pa at 20 °C. Skin contact during use as a textile fiber lubricant/finish is likely and the absorption through the skin is anticipated to be identical to the oral or inhalation routes of exposure. Information has been presented for both acute oral and dermal toxicity. Additionally, the toxicokinetics assessment indicates that exposure via oral, dermal or inhalation will result in comparable adsorption, distribution, metabolism, and excretion. Therefore, further testing of the acute inhalation toxicity is not scientifically necessary as the available toxicity studies adequately represent the toxicity profile of the registered substance.
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 substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The acute oral LD50 is > 5000 mg/kg bw. Therefore, according to EC 1272/2008 as amended, the test substance does not meet the criteria for acute toxicity (oral) classification.

As no systemic effects have been reported following oral exposure and toxicokinetic assessments do not anticipate a significant difference in toxicity based on route of exposure, acute toxicity via dermal exposure or via inhalation is not anticipated. Therefore, according to EC 1272/2008 as amended, the test substance does not meet the criteria for acute toxicity classification.

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