Alcohols, C20-22, reaction products with phosphorus oxide (P2O5)

Endpoint summary

Description of key information

2 acute oral and dermal toxicity studies were performed with the registered substance.No mortality was observed. LD50 oral and dermal > 2000 mg/kg.

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:

2000-04-19 to 2000-06-16

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Twenty OFA Sprague Dawley rats (SPF Caw) originated from IFFA CREDO (69210 L’Arbresle –France), were kept during a 5-day acclimatisation period. At the beginning of the study, the animals weight was contained between 173 g and 195 g (males) and between 164 g and 179 g (females).
Control group: 5 male rats and 5 female rats
Treated group: 5 male rats and 5 female rats

Environmental parameters:
- temperature : between 19°C and 23°C
- relative humidity: between 47% and 59%

Route of administration:

oral: gavage

Vehicle:

paraffin oil

Details on oral exposure:

As the test product was presented as solid form, the following solution has been prepared:
6 g of the test product reduced in powder with a mortar was mixed with parafin oil (q.s.p. 60 ml) under magnetic shaking to obtain a solution at 2g/20 ml.

Doses:

2000 mg/kg bw in a volume 20 ml/kg bw

No. of animals per sex per dose:

5 female rats
5 male rats

Control animals:

yes

Details on study design:

- 2 groups rats: control (vehicle= paraffin oil) and treated rats
- treatment: 2000 mg/kg bw in 20 ml/kg bw
- administration by fore-feeding using suitable syringue graduated fitted with an oesophageal metal canula
- clinical observation of the rats: 1, 5, 24 and 48 hours after the gavage
- body weight evolution: 2, 7 and 14 days after the gavage
- macroscopical examination if the rats at the end if the study (D14)

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortality occured during the study

Clinical signs:

other: No clinical signs related to the administration of the test product were observed.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test product is higher than 2000 mg/kg body weight by oral route in the rat.

Executive summary:

The test product was administered to a group of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight according to the experimental protocol established on the basis of the official method as defined in the O.E.C.D. guideline no 401 dated February 24th, 1987 and the test method B.1 of the E.E.C. Directive no 92/69 dated December 29th, 1992. No mortality occurred during the study. No clinical signs related to the administration of the test product were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50 of the product LCE00051 is higher than 2000 mg/kg body weight by oral route in the rat. According to the criteria for classification, packaging and labelling of dangerous substances in accordance with the E.E.C. Directives 67/548 and 93/21, the product LCE00051 must not be classified.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Clinical signs:

other:

Conclusions:

Effects upon inhalation of the substance were not investigated. This is not required as acute toxic potential was investigated for two other routes (oral and dermal), the product is non-volatile (vapour pressure of 6.66 X 10-5 Pa) and the granulometry of the product (only 0.7% of paticules are smaller than 100µm as the product is in the form of pellets or flakes) would lead to negligible exposure of terminal airways.

Executive summary:

Effects upon inhalation of the substance were not investigated. This is not required as acute toxic potential was investigated for two other routes (oral and dermal), the product is non-volatile (vapour pressure of 6.66 X 10-5 Pa) and the granulometry of the product (only 0.7% of paticules are smaller than 100µm as the product is in the form of pellets or flakes) would lead to negligible exposure of terminal airways.

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:

experimental study

Adequacy of study:

key study

Study period:

2008-01-02 to 2008-03-03

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Twenty Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St Isle – France), were used after an acclimatisation period of at least five days. At the beginning of the study, the animals of the treated group weighed between 225 g and 240 g (males) and between 199 g and
212 g (females) and were 6-8 weeks old.
During the treatment, the animals were kept in individual cage. At D3, the animals were put into their cage by 2 or 3. The rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry; the environmental conditions were:
- temperature : between 20 °C and 23 °C
- relative humidity : between 32 % and 62 %
- lighting time: 12 hours daily
Drinking water (tap-water from public distribution system) and foodstuff were supplied freely.
Microbiological and chemical analyses of the water were carried out once every six months by the Institut Européen de l'Environnement de Bordeaux (I.E.E.B.).

Type of coverage:

semiocclusive

Vehicle:

paraffin oil

Details on dermal exposure:

Animals from the treated group received by topical application, under porous gauze dressing, an effective dose of 2000 mg/kg body weight of the product, diluted in liquid paraffin under a volume of 10 mL/kg body weight, during 24 hours. After 24-hour exposure period, the gauze dressings were removed.
Animals from Control Group received in the same experimental conditions the control item (distilled water) under a volume of 2 mL/kg body weight.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw in 10 ml/kg bw

No. of animals per sex per dose:

Control group: 5 male and 5 female rats
Treated group (1 dose): 5 male and 5 female rats

Control animals:

yes

Details on study design:

- 2 groups of rats: 10 controls (treated with distilled water) and 10 treated animals (2000 mg/kg bw)
- topical application, under porous gauze dressing for 24 hours
- after gauze dressing removal, clinical observation 1, 3 and 5 hours and each day for 14 days
- weight evolution 2, 7 and 14 days after the topical application
- autopsy at the end of the study, Day 14 and macroscopic observations of the main organs.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred during the study.

Clinical signs:

other: Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test product is higher than 2000 mg/kg body weight by dermal route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test product must not be classified. No symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item needs not be classified in category 4. No signal word and hazard statement are required.

Executive summary:

The test product was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline. n° 402 dated February 24th, 1987 and the test method B.3 of the directive. n° 92/69/EEC. No mortality occurred during the study. Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50 of the test product is higher than 2000 mg/kg body weight by dermal route in the rat. According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test product must not be classified. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item needs not be classified in category 4. No signal word and hazard statement are required.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

The acute toxicity was tested in rats using the two usual routes of administration: oral and dermal. Each key study is quoted as reliability 1 according to Klimisch criteria (OECD studies and performed in accordance with GLP).

Acute toxicity: oral

The test product was administered to a group of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight according to the experimental protocol established on the basis of the official method as defined in the O.E.C.D. guideline no 401 dated February 24th, 1987 and the test method B.1 of the E.E.C. Directive no 92/69 dated December 29th, 1992. No mortality occurred during the study. No clinical signs related to the administration of the test product were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50 of the product LCE00051 is higher than 2000 mg/kg body weight by oral route in the rat.

Acute toxicity: dermal

The test product was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline. n° 402 dated February 24th, 1987 and the test method B.3 of the directive. n° 92/69/EEC. No mortality occurred during the study. Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50 of the test product is higher than 2000 mg/kg body weight by dermal route in the rat.

Justification for classification or non-classification

C20-C22 Alkym Phosphate induces no mortality in the rat following a single exposure by oral and dermal route up to a limit dose/concentration and thus should not to be classified for acute toxicity via the oral and dermal route as defined by UN/EU GHS classification criteria.