Registration Dossier

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:
other: GLP compliant OECD guideline 402 study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(1987)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste
Details on test material:
- Name of test material (as cited in study report): Fatty alcohol ether sulfate, sodium salt, C8-10 2EO
- Physical state: White paste
- Analytical purity: 97.13%
- Lot/batch No.: 153422/001
- Expiration date of the lot/batch: 2013-02-01
- EO degree: 2

Test animals

Species:
rat
Strain:
other: WISTAR rats Crl: WI(Han)
Sex:
male/female
Details on test animals 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:
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 was observed beginning on day 6 (10/10 animals both). Desquamation was observed in 7/10 animals until study termination. Scratches were observed in 2 of 5 females.
Body weight:
A decreased body weight was observed for 3/5 females during the first week. However, all females gained weight during the second week. The effects on body weight might be secondary due to the dressing and are considered to be of no toxicological relevance.
The males gained weight throughout the whole study period. For details see table 1 in "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.

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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified