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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Golpanol PAP
IUPAC Name:
Golpanol PAP
Details on test material:
- Name of test material (as cited in study report): Golpanol PAP / 2-Propyn-1-ol, compd. with methyloxirane
- Physical state: liquid
- Analytical purity: approx. 50%
- Impurities (identity and concentrations): < 1% Propargylalcohol, approx. 35% water, approx. 7% Propylenglycol, aprox. 7% higher alcoxylated products

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Weight at study initiation: male (mean): 186g, female (mean): 184g
- Fasting period before study: 16 hours
- Housing: 5 animals per cage (grouped according to doses)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Air changes (per hr): fully airconditioned
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
215, 464, 2150, 5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once per day (observation), after 7 and 13 days (weighing)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 464 - < 2 150 mg/kg bw
Based on:
test mat.
Remarks on result:
other: all male and female animals dosed with 2150mg/Kg died after 1 day, 2/5 males dosed with 464mg/Kg died after 7 days, 0/5 females dosed with 464mg/Kg died until the end of the study
Sex:
female
Dose descriptor:
LD50
Effect level:
> 464 - < 2 150 mg/kg bw
Based on:
test mat.
Remarks on result:
other: all female animals dosed with 2150mg/Kg died after 1 day; all female animals dosed with 464mg/Kg survived until the end of the study
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 464 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 2/5 male animals dosed with 464mg/Kg died 7 days after treatment
Mortality:
male/female:
5000mg/Kg: 5/5 animals after 1 day
2150mg/Kg: 5/5 animals after 1 day

male:
464mg/Kg: 2/5 animals after 7 days

No mortality was observed after administration of 215 mg/kg in males and females as well as after treatment of females with 464 mg/kg.

female:
5000mg/Kg: 5/5 animals after 1 day
2150mg/Kg: 5/5 animals after 1 day
Clinical signs:
other: 5000mg/Kg, males and females: dyspnea, apathy, abnormal position, atonia, paresis, poor general state after <15min - 4h staggering: <15min - 1h exsiccosis: 4h piloerection: 1h - 4h 2150mg/Kg, males and females: dyspnea, apathy, staggering, paresis, poor
Gross pathology:
male and female animals that died spontaneously on day 1 or 7:
general congestion, liver: lobular perphery yellow brown, stomach: bloody ulceration in the glandular stomach

sacrified animals (male, female): no pathological findings

Any other information on results incl. tables


LD50 male animals: ca. 464 mg/kg; LD50 female animals > 464 < 2150 mg/kg

Applicant's summary and conclusion