Poly(oxy-1,2-ethanediyl), .alpha.-sulfo-.omega.-hydroxy-, C8-10-alkyl ethers, sodium salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 Aug - 27 Aug 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted in 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C8-10, ethoxylated, sulfates, sodium salts

EC Number:

939-523-2

Cas Number:

1471312-55-6

Molecular formula:

not available

IUPAC Name:

Alcohols, C8-10, ethoxylated, sulfates, sodium salts

Test material form:

semi-solid (amorphous): gel

Remarks:

paste

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI(Han)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: males: 7 - 8 weeks, females: 11 - 12 weeks
- Body weight at study initiation: males: 221 – 235 g, females: 212 – 229 g.
- Diet (ad libitum): Altromin 1324 maintenance diet for rats and mice (lot no. 0939)
- Water (ad libitum): tap water, sulphur acidified to a pH value of approximately 2.8
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: approx. 10%
REMOVAL OF TEST SUBSTANCE
- Washing: The residual test item was removed using aqua ad injectionem
- Time after start of exposure: 24 h

Duration of exposure:

24 h

Doses:

2000 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
- Frequency of observations and weighing: A careful clinical examination was made several times on the day of dosing. Thereafter, the animals were observed for clinical signs once daily. The animals were weighed on Day 1 (prior to the application) and on Days 8 and 15.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No mortality occured.

Clinical signs:

other: No clinical signs of toxicity occurred.

Body weight:

lower than 10% body weight loss

Remarks:

For details, please refer to Table 1 under "Any other information on results incl. tables".

Gross pathology:

Upon gross pathology hernia (liver) into the diaphragm was observed in one female. This incidental finding is not considered to be treatment related.

Other findings:

Signs of irritation:
Erythema grade 1 as well as eschar and desquamation were observed in 10/10 animals. Scratches were observed in 2/5 females. In 3/5 males and 4/5 females, all signs of irritation were not reversible within the observation period.

Any other information on results incl. tables

Table 1: Absolute Body Weights in g and Body Weight Gain in %

Animal No. / Sex	Day 1	Day 8	Day 15	Day 1-15
21 / male	226 g	241 g	282 g	25 %
22 / male	231 g	250 g	292 g	26 %
23 / male	230 g	238 g	274 g	19 %
24 / male	221 g	236 g	270 g	22 %
25 / male	235 g	245 g	282 g	20 %
Mean ± SD	229 ± 5.3 g	242 ± 5.6 g	280 ± 8.5 g	22 ± 3.0 %
26 / female	213 g	215 g	220 g	3 %
27 / female	216 g	213 g	217 g	0 %
28 / female	212 g	205 g	216 g	2 %
29 / female	229 g	227 g	250 g	9 %
30 / female	217 g	223 g	234 g	8 %
Mean ± SD	217 ± 6.8 g	217 ± 8.6 g	227 ± 14.6 g	4 ± 3.9 %

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

This study was performed according to OECD test guideline 402 and compliant with GLP. Under the conditions of this limit test, the median lethal dose (LD50) of the test item (technical substance) after a single 24-h dermal administration was found to be greater than 2000 mg/kg bw in male and female Crl:WI Wistar rats. It is concluded that the CLP/ EU GHS criteria are not met and that no classification is required according to Regulation (EC) No 1272/2008.