Amines, C12-14-alkyl, C6-10-alkyl phosphates

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

November 13, 1981 - December 2, 1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Refer to the section 13 of IUCLID dataset for details on the read across justification. The acute oral toxicity study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Tif: RAIf (SPF), F3-crosses of RII 1/Tif x RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Ltd., Tierfarm, CH-4332 Sisseln
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 163 - 190 g
- Fasting period before study: over night, prior to dosing
- Housing: groups of 5 in macrolon cages type 3 with standardized soft wood bedding
- Diet: rat food, Nafag No. 890
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days or until all symptoms have disappeared, whichever lasts longer
- Frequency of observations: daily
- Frequency of weighing: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes

Statistics:

For the body weights, the group means and their standard deviation were calculated.
The LD50 including the 95 % confidence limit were computed by the logit method.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

1 female animal died 2 days post application.

Clinical signs:

other: Dyspnoea, ruffled fur and curved body position were observed directly after application and lasted up to day 7 post application. For several hours or days, respectivley, sedation and diarrhoea was also observed. All clinical signs were reversible within t

Gross pathology:

No compound related gross organ changes were observed.

Dose (mg/kg bw)	Day 1	Day 7	Day 14
	Males
5000	182 (5.8)	206 (9.3)	250 (15.7)
	Females
5000	171 (5.2)	178 (6.9)	202 ( 5.5)

Interpretation of results:

GHS criteria not met

Conclusions:

Upon an acute oral administration and a 14 day post-treatment observation period, an LD50 of > 5000 mg/kg bw was determined in the rat.

Executive summary:

A study was conducted to determine the acute oral toxicity of the read-across substance amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates according to OECD Guideline 401, under GLP conditions. Groups of 5 rats per sex were administered the test substance at an oral gavage dose of 5000 mg/kg bw and observed for 14 days post dose for mortality, clinical signs, and body weight. Following observation period, the treated animals were sacrificed to observe gross pathological signs in the internal organs. No mortality was observed througout the study. Under the study conditions, the acute oral LD50 of the substance was determined to be greater than 5000 mg/kg bw (Sarasin, 1981).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source of animals: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
Initiral body weight range: 177-239 g
Initial age: 7-8 weeks
Husbandry: The animals were kept under conventional laboratory conditions. They were caged individually in Macrolon cages type 2 with standardized soft wood bedding (Societe Parisienne des
sciures, Pantin). The animal room was air conditionned: temperature 22+3C, relative humidity 55±15%, 12 hours light/day, approximately 15 air changes/h.
Food: NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland),and water were provided ad libitum.

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes, concurrent no treatment

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the acute dermal LD50 of the substance was determined to be greater than 2000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute dermal toxicity of the substance according to OECD Guideline 402, under GLP conditions. Groups of 5 rats per sex were administered the test substance at a topical dose of 2000 mg/kg bw on the shaved skin of the back with a semiocclusive bandage. The exposure was for 24 h following which the test substance was washed with water and the treated animals were observed for 14 days post dose for mortality, clinical signs, and body weight. Following observation period, the treated animals were sacrificed to observe gross pathological signs in the internal organs. No mortality was observed througout the study. Under the study conditions, the acute dermal LD50 of the substance was determined to be greater than 2000 mg/kg bw (Kobel, 1984).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

A study was conducted to determine the acute oral toxicity of the read-across substance amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates according to OECD Guideline 401, under GLP conditions. Groups of 5 rats per sex were administered the test substance at an oral gavage dose of 5000 mg/kg bw and observed for 14 days post dose for mortality, clinical signs, and body weight. Following observation period, the treated animals were sacrificed to observe gross pathological signs in the internal organs. No mortality was observed througout the study. Under the study conditions, the acute oral LD50 of the substance was determined to be greater than 5000 mg/kg bw (Sarasin, 1981).

A study was conducted to determine the acute dermal toxicity of the read-across substance amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates according to OECD Guideline 402, under GLP conditions. Groups of 5 rats per sex were administered the test substance at a topical dose of 2000 mg/kg bw on the shaved skin of the back with a semiocclusive bandage. The exposure was for 24 h following which the test substance was washed with water and the treated animals were observed for 14 days post dose for mortality, clinical signs, and body weight. Following observation period, the treated animals were sacrificed to observe gross pathological signs in the internal organs. No mortality was observed througout the study. Under the study conditions, the acute dermal LD50 of the substance was determined to be greater than 2000 mg/kg bw (Kobel, 1984).

Justification for classification or non-classification

Based on the results of the read across studies through oral and dermal routes, the substance does not warrant any classification according to EU CLP (1272/2008/EC) criteria.