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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-06-02 to 2004-06-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): AE 425/03
- Physical state: weak yellowish, solid
- Analytical purity: > 80 %
- Lot/batch No.: 11/2003
- Expiration date of the lot/batch: December 2004
- Storage condition of test material: dry, cool and dark
- Other:

A purity of > 80 % is recorded for AE 425/03 (batch 11/2003) in the study report, however, according to additional sponsor´s information this value applies to the content of the quaternised mono- di- and triesters of fatty acids with triethanolamin whereas the value of the complete UVCB substance is 100 %.

Test animals

Species:
rat
Strain:
other: CD, Crl. CD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at study initiation: (start of adaptation) males 43 days; females 55 days
- Weight at study initiation: males: 224- 252 g; females: 200 - 211 g
- Fasting period before study: 16 hours before admininstration
- Housing: singly in Makrolon cages typ III, granulated texture wood beeding
- Diet: ad libitum ssniff R/M-H V 1534; Ssniff Spezialdiäten GmbH, D-59494 Soest
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): no data
- Photoperiod: 12 hour dark/light cycle

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 x 6 cm, approx 10 % of body surface
- % coverage: no data
- Type of wrap : The test item suspension was applied to 8 layers of gauze. The gauze was covered with a plastic sheet and secured with
adhesive plaster on the application site.

The test substance was administrated dermal, on the shaved intact dorsal skin.

REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the exposure period no residual test item had to be removed

TEST MATERIAL
The test substance was suspended in aqua ad injectabilia
Administrated volume: 10 mL/kg bw
Dose level: 2000 mg/kg bw

VEHICLE
aqua ad injectabilia
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hrs
after administration, thereafter at least once daily.
Individual body weights were recorded before administration of the test substance and thereafter in weekly intervals up to the end of the study.
During the follow-up period, changes of skin and fur, eyes and mucous membranes, respiratory and circulatory function, autonomic and central
nervous system and somatomotor activity as well as behavior pattern were observed at least once a day until all symptoms subsided, thereafter
each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhea, lethargy, sleep and coma.
- Necropsy of survivors performed: All surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes
were recorded. No histopathology was carried out as no macroscopic findings were noted at necropsy.

other: skin irritation was scored according to the Draize scheme.
Statistics:
N/A

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no animal died
Mortality:
no animal died
Clinical signs:
no signs of toxicity were observed
Body weight:
Normal weight gain was observed, except for one female rat. Its body weight gain appeared to be slightly reduced.
Gross pathology:
No marcroscopical changes were noted at necropsy.
Other findings:
No erythema or oedema were observed. All readings were 0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met