9-Octadecen-1-ol, (Z)-, phosphate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013-03-19 to 2013-04-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: CLP and Guideline compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

, adopted 24th February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

, 31.05.2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

, adopted August, 1998

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

UVCB: not applicable

IUPAC Name:

UVCB: not applicable

Constituent 2

Reference substance name:

UVCB: not applicable

IUPAC Name:

UVCB: not applicable

Constituent 3

Reference substance name:

9-Octadecen-1-ol, (Z)-, phosphate

EC Number:

253-455-4

EC Name:

9-Octadecen-1-ol, (Z)-, phosphate

Cas Number:

37310-83-1

Molecular formula:

C18H37O4P

IUPAC Name:

[(9Z)-octadec-9-en-1-yloxy]phosphonic acid

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90.
- Age at study initiation: Young adult rats, females were nulliparous and non-pregnant
- Weight at study initiation: Male 230-248 g, Female 233-263 g
- Fasting period before study: food but not water was withheld overnight
- Housing during acclimasation: 3 animals/sex/cage and during the study: animals were housed individually
- Diet: ad libitum (ssniff® SM R/M-Z+H complete diet )
- Water: ad libitum
- Acclimation period: 5 days (males), 47 days (females)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10-15 air exchanges/hour by central air-condition system.
- Photoperiod: Artificial light, from 6 a.m. to 6 p.m.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: approximately 10 % of the total body surface
- The vial with the test item was opened shortly before being moistened and applied.
- Type of wrap if used: sterile gauze pad below a semi-occlusive plastic wrap

REMOVAL OF TEST SUBSTANCE
- residual test item was removed, using helianthi oleum raffinatum as an appropriate solvent
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: Limit test: 2000 mg/kg bw

Duration of exposure:

single administration for 24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the body weight of all animals were recorded on day 0 (shortly before the treatment), on day 7 and on day 15 (with a precision of 1 g)
- Necropsy of survivors performed: yes
- Other examinations performed: Animals were observed individually 1 h and 5 h after dosing, and once each day for 14 days thereafter. Observations included the skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous system, and somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
All animals were subjected to gross pathology. All animals were exsanguinated under isoflurane anaesthesia on day 15. After examination of the external appearance the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed. All gross pathological changes were recorded for each animal on the post mortem record sheets.

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality occured

Clinical signs:

other: General symptoms No behavioural changes or systemic toxic signs were noted during the study. Dermal irritation symptoms as erythema (redness), oedema and other signs were observed on the treatment site. The very slight (score 1) redness, well defined (sc

Gross pathology:

All animals survived until the scheduled necropsy on Day 15.
Slight hydrometra was observed in one female and moderate hydrometra was found in two females. Hydrometra was an indication for the sexual cycle of female animals and is a frequent observation in experimental rats with no toxicological meaning.
No macroscopic alterations due to the systemic toxic effects of the test item were found.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In this acute dermal toxicity study with the test item Reaction product of oleylalcohol with polyphosphoric acid, the obtained acute dermal LD50 value was higher than 2000 mg/kg bw in male and female Crl:(WI)BR rats.

Executive summary:

A limit test was carried out. A single group of male and female animals (n=5 animals/sex) was exposed to Reaction product of oleylalcohol with polyphosphoric acid at 2000 mg/kg bw by dermal route. The test item was applied in its original form and left in contact with the skin for 24 hours, followed by a 14-day observation period.

 The results of the study were summarised as follows:

No mortality occurred during the study.

Dose	2000 mg/kg bw
Male	5
Mortality	0/5
Female	5
Mortality	0/5

 

Neither male nor female animals treated at 2000 mg/kg bw showed behavioural changes and no systemic toxic signs were noted during the study.

The test item caused dermal irritation symptoms as slight to severe erythema, slight oedema and other signs as wounds, crusting and desquamation between Day 1 and Day 14 in males and between Day 1 and Day 11 in females.

Very slight body weight variations were observed in two females during first week and also in one out of the two females during second week.

The body weight development was undisturbed in all male animals.

No macroscopic alterations of organs and tissues referred to the systemic toxic effect of the test item were seen during the necropsy.

In this acute dermal toxicity study with the test item Reaction product of oleylalcohol with polyphosphoric acid, the obtained acute dermal LD50 value was higher than 2000 mg/kg bw in male and female Crl:(WI)BRrats.