Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1992-04-28, 1992-07-07
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Reliability of the original study is 1
Justification for type of information:
Justification for Read Across is given in Section 13 of IUCLID

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
84/449 EEC, B.3
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Tif: RAI f (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Ltd., Animal Production, Stein, Switzerland
- Weight at study initiation: 217 - 240 g
- Housing: individually in Macrolon cages type 3, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet: NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland
- Water: tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Air changes: 15 per hr
- Photoperiod: 12 hrs dark /12 hrs light

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
arachis oil
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: at least 10 % of the body surface
- Type of wrap if used: gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg body weight

VEHICLE
- Amount(s) applied: 4 ml/kg bw
Duration of exposure:
24 hours
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: daily (mortality, signs, and symptoms); immediately before application and on days 7 and 14 (weight)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

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 was observed.
Mortality:
None.
Clinical signs:
Piloerection was seen, being a common symptom in acute dermal tests. The animals recovered within 2 days.
Body weight:
Animals gained body weight as expected.
Gross pathology:
No deviations from normal morphology were found.

Any other information on results incl. tables

Table: Body Weights (g) and Standard Deviation

Dose (mg/kg bw)

Day 1

Day 7

Day 14

 

Males

5000

234 (9.0)

265 (6.3)

296 (19.7)

 

Females

5000

223 (6.2)

227 (12.5)

239 ( 13.9)

Applicant's summary and conclusion

Interpretation of results:
other: not classified as harmful/toxic according to the CLP Regulation (EC) No 1272/2008
Conclusions:
LD50 > 2000 mg/kg bw
Executive summary:

The acute dermal toxicity of the test material was evaluated according to the OECD Guideline 402 and EU Method B.3. Five male and five female rats were exposed to 2000 mg/kg bw of the substance (at the back) for 24 hours in a semiocclusive coverage. After the exposure period the substance was removed and the animals were observed for 14 days for mortality, signs and symptoms. The survived animals were submitted to a gross necropsy at the end of the observation period. Body weight measurements were done immediately before application and on days 7 and 14.

No mortality nor gross pathological changes were noted. Piloerection was seen, being common symptoms in acute dermal tests; the animals recovered within 2 days. Body weight gain was observed.

LD50 > 2000 mg/kg bw