Alcohols, C12-14, ethoxylated, sulfates, sodium salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

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:

(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:

Fatty alcohol ether sulfate, sodium salt, C8-10 2EO

IUPAC Name:

Fatty alcohol ether sulfate, sodium salt, C8-10 2EO

Test material form:

semi-solid (amorphous): gel

Test animals

Species:

rat

Strain:

other: WISTAR rats Crl: WI(Han)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: males: 7-8 weeks, females: 11-12 weeks
- 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 five 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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occured.

Mortality:

No mortality occured.

Clinical signs:

other: No clinical signs of toxicity occurred. Signs of dermal irritation were observed. Erythema grade 1 was observed on 10/10 animals on day 4 which was fully reversed on day 5 on all animals. Eschar formation was observed from day 4 to day 8 and desquamation

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.

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.