Registration Dossier

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:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
24 February, 1987
GLP compliance:
yes (incl. certificate)
Remarks:
Országos Gyógyszerészeti és Élelmezés-egészégügyi Intézet
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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:
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.
Body weight:
The mean body weight of all animals corresponded to their species and age throughout the study.
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.