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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:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline Study, Source substance for RA information according to analogue justification.

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)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: liquid
- Analytical purity: 54.7 area %
- Impurities (identity and concentrations): 33.9 g/100 g water, propargyl alcohol 0.6 area %, propylene glycol 5.3 area %, higher alcoxylated products 5.4 area %
- Lot/batch No.: 88767924U0
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor,
and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: Young adult animals (male animals approx. 8 weeks, female animals approx. 12 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight)
- Housing: Single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Acclimatization period of at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: unchanged or water
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal and dorsolateral parts of the trunk
- % coverage: 40 cm² (corresponds to at least 10% of the body surface)
- Type of wrap if used: semi- occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: after 24 hours of exposure
Duration of exposure:
24 hours
Doses:
500 and 2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of
observation. Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross-pathology
Statistics:
Not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
No systemic clinical signs were observed in the test groups during clinical examination in addition also no local effects were observed on the skin.
Body weight:
The mean body weight of the male animals increased throughout the study period within the normal range (2000 mg/kg bw: 5 males; 500 mg/kg bw: 5 males).
The mean body weights of the female animals stagnated during the first post-exposure observation week probably due to the bandage procedure, but increased during the second week within the normal range (2000 mg/kg bw: 5 females; 500 mg/kg bw: 5 females).
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (examined on the last day of observation (2000 mg/kg bw: 5 males and 5 females; 500 mg/kg bw: 5 males and 5 females)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
At maximal concentration (2000 mg/kg bw) no mortality occured, therefore the LD50 was determined to be > 2000 mg/kg bw.
Executive summary:

In an acute dermal toxicity study (OECD 402), 5 young adult Wistar rats of both sexes were dermally exposed to doses of 2000 mg/kg and 500 mg/kg bw of 2-Propyn-1-ol, compd. with methyloxirane to the clipped skin and covered by semi-occlusive dressing for 24 hours under GLP conditions. The application area comprised at least 10% of the total body surface area.

The animals were observed for 14 days, where no mortality occurred and no other signs of systemic toxicity were observed.

 

Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 2000 mg/kg bw and no classification concerning GHS (EU) is recommended. (BASF 2013)