Sodium 2-butoxyethyl sulphate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 July 2017 - 18 Oct 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February, 1987

GLP compliance:

yes (incl. QA statement)

Remarks:

Országos Gyógyszerészeti és Élelmezés-egészégügyi Intézet

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 2-butoxyethyl sulphate

EC Number:

266-840-7

EC Name:

Sodium 2-butoxyethyl sulphate

Cas Number:

67656-24-0

Molecular formula:

C6H14O5S.Na

IUPAC Name:

sodium 2-butoxyethyl sulphate

Test material form:

solid

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
- Females nulliparous and non-pregnant: yes
- Age at study initiation: not reported
- Weight at study initiation: 211-238 g for males; 230-253 g for females
- Fasting period before study: not reported
- Housing: 3 animals/sex/cage during acclimatization; individually housed during study
- Diet: ssniff® SM R/M-Z+H complete diet provided ad libitum
- Water: tap water provided ad libitum
- Acclimation period: 19 days for females, 5 days for males

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: backs of animals
- % coverage: approximately 10% area of the total body surface
- Type of wrap if used: sterile gauze pads held by with adhesive hypoallergenic plaster and wrapped with semi occlusive plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing: yes; removed using appropriate vehcile
- Time after start of exposure: 24 h

TEST MATERIAL
- Concentration: 2000 mg/kg bw/day
- For solids, paste formed: no, original form

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Inspection for signs of morbidity and mortality were made twice daily at the beginning and end of the working day. Clinical observations were made at the following intervals: 1h, 5h after the treatment and once each day for 14 days thereafter. Skin reaction observations were made at 1 hour as well as 24, 48 and 72 hours after removal of the patch. The body weight was recorded on day 0 (shortly before the treatment), on day 7 and on day 15 with a precision of 1 g in main study.
- Necropsy of survivors performed: yes; after examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed, and any abnormality was recorded with details of its location, colour, shape and size.

Results and discussion

Preliminary study:

No deaths were observed in the preliminary study after females were treated with 50, 200, 1000 or 2000 mg/kg bw/kg of the test item.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred after the 24-hour dermal exposure to Butylmonoglycol sulphate, Na-salt in male and female rats during the study.

Clinical signs:

other: No behavioral changes or signs of systemic toxicity were noted during the study. Similarly, no local symptoms (dermal irritation as erythema and edema) were observed on the treated skin of animals.

Gross pathology:

No test item related pathological changes were found during the macroscopic examination of animals.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.

Conclusions:

In summary, the acute dermal LD50 value for male and female rats was considered to be greater than 2000 mg/kg bw. Therefore, the test substance does not need to be classified for acute dermal toxicity according to Regulation (EC) No 1272/2008.