Sodium salts of Mono- and di-[reaction products of dodecyl alcohol and ethylene oxide]phosphates

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

From 28 February 2000 to 27 October 2003

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is a screening test but followed international guidance requirements with acceptable restrictions.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

screening study: 2 doses tested, 3 animals/dose, no certificate of analysis included

Principles of method if other than guideline:

Screening test with 2 groups of animals treated with 500 (male) or 2000 (female) mg/kg bw

GLP compliance:

no

Test type:

other: screening test

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

other: liquid at ambient temperature

Details on test material:

- Name of test material (as cited in study report): Dermalcare MAP L-213/K
- Physical state: clear liquid
- Stability under test conditions: assumed to be stable by the sponsor
- Storage condition of test material: ambient temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan (Italy S.r.l.)
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: yes, overnight prior dosing
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

methocel 0.5% in sterile water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50 and 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual): not applicable

CLASS METHOD (if applicable)
not applicable

Doses:

500 and 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: immediately upon dosing, approximately 1, 2 and 4 hrs after dosing and then daily. Animals were weighed on days 1 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, gross necropsy for external and internal abnormalities

Statistics:

not applicable

Results and discussion

Preliminary study:

not applicable

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD0

Effect level:

>= 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality

Effect levels 2

Sex:

female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality

Mortality:

No mortality was observed

Clinical signs:

other: Piloerection was noted on the day of dosing in both sexes. Recovery was observed on day 2.

Gross pathology:

no abnormalities were found

Other findings:

no other findings

Any other information on results incl. tables

no other results

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the test item Dermalcare MAP L-213/K is not classified for acute oral toxicity in rats as LD50 is higher than 2000 mg test material/kg bw.

Executive summary:

In an acute oral toxicity screening study, performed similarly to the OECD guideline No. 401, groups of Sprague Dawley male and female rats (3 animals/sex) were given a single oral dose of Dermalcare MAP L-213/K by gavage at doses of  500 (male) and 2000 (female) mg/kg bw. The test item was suspended in carboxymethyl cellulose 0.5% in sterile water. Clinical signs, mortality and body weight gain were checked for a period of up to 14 days. All animals were sacrificed at the end of the study and necropsied for gross abnormalities.

 

Oral LD₅₀in male rats > 500 mg test material/kg bw

Oral LD₅₀in female rats > 2000 mg test material/kg bw

 

No mortality occurred in any animals at the tested doses. Pilorection was observed in both sexes but recovery was observed on day 2. No other clinical signs were observed. The necropsy revealed no abnormalities.

 

Under the test conditions, Dermalcare MAP L-213/K is not classified for acute oral toxicity according to the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/EEC.