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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:
6 Aug 1980 to 30 Sep 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Used for read across to Pinyl Isobutyraldehyde
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Based on read across
Justification for type of information:
The read across justification is presented in the acute toxicity endpoint summary and the accompanying files are also attached there.
Reason / purpose:
read-across source
Related information:
Composition 1
Test material information:
Composition 1
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
other: Not acute toxic
Remarks:
in accordance with EU CLP (EC 1272/2008 and its updates)
Conclusions:
Based on the results of the study for read-across substance Floralozone, PIBA is considered to be not acute toxic via the dermal route.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Test material form:
liquid
Details on test material:
As described in 1.2 of dossier

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Perfection Breeders, Nicholas Helf
- Age at study initiation: 8 weeks
- Weight at study initiation: 2.0 – 2.8 kg
- Housing: animals were housed 2 animals per cage in suspended wire mesh cages
- Diet: fresh Purina rabbit chow, ad libitum
- Water: ad libitum
- Acclimation period: at least one week

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: immediately prior to dosing, the fur was clipped from the abdomen. Abrasions were made in ½ of the rabbits. The abrasions, extending the length of the exposure site, scratched the stratum corneum but did not reach the derma or produce bleeding. The test material was applied once to the prepared site under gauze patches.
- % coverage: The clipped area was 200 cm2, approximately 10% of the body surface.
- Type of wrap if used: Patches were secured with adhesive tape and the trunks were wrapped with impervious material.

REMOVAL OF TEST SUBSTANCE
- Washing: the exposure site was wiped, but not washed
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 5000 mg/kg bw
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
6 males and 4 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Dermal reactions were scored at 1, 7 and 14 days after exposure. Animals were observed daily for signs of toxicity, pharmacological effects and mortality.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
Animals were in generally good health.
Body weight:
Changes in body weights were generally normal. One animals lost 0.3 kg during the study.
Gross pathology:
Internal organs, on superficial examination, appeared normal.
Other findings:
Skin reactions were generally slight on days 1 and 7 and generally cleared by day 14. One animal had severe edema on day 1 and crusted skin at necropsy on day 14. Scaly skin was observed in 6 out of 10 animals at necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: Not acute toxic
Remarks:
in accordance with EU CLP (EC 1272/2008 and its updates)
Conclusions:
The acute dermal toxicity test showed an LD50 > 5000 mg/kg bw. Based on this result, the substance is considered to be not acute toxic via the dermal route.
Executive summary:

Floralozone was tested in an acute dermal toxicity study similar to OECD TG 402 under GLP. Ten New Zealand White rabbits were exposed to the test substance via dermal application. Six males and four females were exposed to 5000 mg/kg bw. After an observation period of 14 days animals were necropsied. All animals survived the study in generally good health. Changes in body weights were generally normal. Internal organs, on superficial examination, appeared normal. Skin reactions were generally slight on days 1 and 7 and generally cleared by day 14. One animal had severe edema on day 1 and crusted skin at necropsy on day 14. Scaly skin was observed in 6 out of 10 animals at necropsy. The LD50 was determined to be higher than 5000 mg/kg bw.