Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May-June 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study, limited data on details of dermal exposure

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
solid
Specific details on test material used for the study:
Information from study report:
- Name of test material: Emulgator E30, Fest
- CAS number: 5896-54-8
The CAS number in report (5896-54-8) is misleading, since this CAS number does only represent 1-Penta-decanesulfonic acid, sodium salt (1:1), but it is confirmed that the substance used is correctly assigned to CAS 68188-18-1.
- Appearance/Further information: The test substance was supplied as white wax-like leaf-let and was received at the test institute on March 06, 1991.
- Batch No. of test material: 210291
- Purity: 95 %
- Analysis reference: TGL 39237

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation (mean): males 187 g ± 7.8, females 166 g ± 4.4
- Housing: 2-3 rats per cage, Makrolon type III cages
- Diet and water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): approx. 28-40
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE: - % coverage: The test substance was administered on 10 % of the body surface.

TEST MATERIAL: - For solids, paste formed: yes
The test substance was moistenized with 0.2 mL water (Ampuwa, Fresenius, Bad Homburg, Germany) per animal.
Duration of exposure:
not specified in report
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: Once a day, in addition directly after application
- Frequency of weighing: Body weights were determined prestudy, on study day 0 (day of application), and on study days 2, 9 and 14 (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: Organs showing macroscopic changes were preserved in neutral - buffered 10 % formalin and were available for histopathological examinations.
Statistics:
The obtained data were processed to give mean values and standard errors or deviations.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No animal died during the in-life phase.
Clinical signs:
No specific effects were observed during the 14-days observation period. Unspecific irritant effects occurred starting on the first day of application (the dorsal body skin was reddened in all animals). Between the 2nd and the 4th day after application the skin appearance changed to being brownish in colour or to being wrinkled. These changes disappeared between day 8 and 11 p.a.
Body weight:
All rats initially lost weight following exposure to the substance, but recovered and all had gained weight by study conclusion.
Gross pathology:
At necropsy all animals were macroscopically examined and the organs showed some non-specific changes interpreted to be due to the necropsy exsanguination. These alterations were within the normal range of biological variation and no histologic examinations were performed.

Applicant's summary and conclusion

Executive summary:

An acute dermal toxicity study was conducted as a limit test according to OECD TG 402 on 5 male and 5 female rats receiving each a single dose of 2000 mg/kg bw (no data on type of coverage) of the test substance moistened with water. The animals were observed for signs of intoxication during a 14-day postexposure period.

All rats initially lost weight after compound exposure, but recovered and all had gained weight by study conclusion. No specific effects were observed during the 14-day period after the application regarding clinical signs. Unspecific irritant effects occurred starting on the first day of application (the dorsal body skin was reddened in all animals). Between the 2nd and the 4th day after application the skin appearance changed to being brownish in colour or to being wrinkled. These changes disappeared between Day 8 and 11 post application. At necropsy all animals were macroscopically examined and the organs showed some non-specific changes interpreted to be due to the necropsy exsanguination. These alterations were within the normal range of biological variation and no histologic examinations were performed. Since no animal died during the study period the LD50 was concluded to be > 2000 mg/kg bw.