Registration Dossier
Registration Dossier
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EC number: 203-788-6 | CAS number: 110-65-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
Test material
- Reference substance name:
- But-2-yne-1,4-diol
- EC Number:
- 203-788-6
- EC Name:
- But-2-yne-1,4-diol
- Cas Number:
- 110-65-6
- Molecular formula:
- C4H6O2
- IUPAC Name:
- but-2-yne-1,4-diol
- Details on test material:
- - Name of test material (as cited in study report): Butindiol
- Analytical purity: 98.9 % (2.TV), 98.9 % (1.TV)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: male: 7 - 8 weeks, female: 8 -9 weeks
- Weight at study initiation: male: 209 g +/- 12 g female: 199 g +/- 10 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 hours
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- physiological saline
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 30 cm²
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 24 hours, warm water - Duration of exposure:
- 24 hours
- Doses:
- male: 50, 100, 200, 400, 2000 mg/kg b.w.
female: 400, 1250, 1600, 2000 mg/kg b.w. - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 659 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 324 - 1 440
- Sex:
- male
- Dose descriptor:
- other: NOAEL
- Effect level:
- 50 mg/kg bw
- Based on:
- test mat.
- Clinical signs:
- other: reduced spontaneous activity, crouch, retacted flank, constricted palpebral fissure, piloerection, decreased respiratory frequency, high-stepping gait, unsteady gait
Any other information on results incl. tables
Mortality:
| Dose (mg/kg b.w.) | Male animals | Female animals |
| 50 | 0/5 | - |
| 100 | 1/5 | - |
| 200 | 2/5 | - |
| 400 | 2/5 | 0/5 |
| 1250 | - | 3/5 |
| 1600 | - | 3/5 |
| 2000 | 4/5 | 5/5 |
LD50 male animals: 424 (178 - 1880) mg/kg b.w.;
LD50 female animals: 983 (307 - 2440) mg/kg b.w.;
LD50 male + female animals: 659 (324 - 1440) mg/kg b.w.
Applicant's summary and conclusion
- Interpretation of results:
- toxic
- Remarks:
- Migrated information Category 3 Criteria used for interpretation of results: EU
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