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Description of key information

LD50 (oral): > 2000 mg/kg (BASF AG 1994)
LD50 (oral): > 2000 mg/kg (BASF AG 1991)
LD50 (dermal): > 2000 mg (BASF SE 2013)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
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, FRG
- Age at study initiation: Young adult animals
- Weight at study initiation: Animals of comparable weight (150 - 300 g)
- Fasting period before study: 16 h before administration
- Housing: single housing
- Diet (e.g. ad libitum): Kliba-Labordiaet 343, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:
oral: gavage
Vehicle:
olive oil
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality.
Clinical signs:
No abnormality.
Body weight:
The expected body weight gain has been observed in the course of the study.
Gross pathology:
No pathologic findings.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, 97633 Sulzfeld, Germany
- Age at study initiation: Young adult animals (male animals approx. 8 weeks, female animals approx. 11-12 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight)
- Housing: Single housing
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: About 40 cm²
- % coverage: at least 10% of the body surface
- Type of wrap if used:

Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 male /5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight, histopathology, other:
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 during clinical examination.
Skin effects at the application site comprised very slight erythema (grade 1) in all male animals and were observed from study day 1 until day 2.
Skin effects at the application site comprised very slight erythema (grade 1) in two out of five female animals on study day 1; in one of these animals the finding was observed until study day 3, in the other animal very slight erythema increased to well-defined erythema (grade 2) on study day 2 until day 3 and decreased afterwards to very slight erythema until study day 6.
In three out of five female animals well-defined erythema was noted on study day 1 until day 2 or 3 and decreased to very slight erythema on study day 3 or 6, respectively. One of these animals showed erythema grade 1 until day 7.
Very slight edema (grade 1) was noted in four animals from study day 1 until day 2 or 3, respectively. In two of these three animals scaling was noted on study day 7 only or from day 6 until day 7.
Body weight:
The mean body weight of the male animals increased throughout the study period within the normal range. As generally known for females dermally applied, the weight gain only slightly increased during the first week, but increased within the normal range in the second week.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Conclusions:
Under the conditions of this study the median lethal dose (LD50) of Laromer PO 83 F after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Oral

In an acute oral toxicity study (Limit test) according to EU method B1 and GLP (BASF AG 1994), 3 male and 3 female fasted Wistar rats were given a single oral dose of 2000mg/kg in olive oil DAB 10 by gavage. The animals were observerd for 14 days and a necropsy was performed. No mortality occured and no signs of toxicity have not been noted. The expected body weight gain has been observed in the course of the study. No abnormalities were noted at necropsy of animals sacrificed at the end of the study. Thus the oral LD50 value for this substance is greater than 2000 mg/kg b.w.

In an second study (BASF-Test) 5 male and 5 female Wistar rats were given a singel oral dose of 2000 mg/kg in olive oil DAB 9 by gavage. The animals were observerd for 14 days and a necropsy was performed. No mortality occured and no signs of toxicity have not been noted. No abnormalities were noted at necropsy of animals sacrificed at the end of the study. Thus the oral LD50 value for this substance is greater than 2000mg/kg b.w. (BASF AG 1991)

 

Dermal

In an acute dermal toxicity study (Limit Test) (OECD 402), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of Propylidynetrimethanol, ethoxylated, propoxylated esters with acylicacid, reaction products with 1 -Butanamine, N-butyl- (>1<6.5) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. No signs of systemic toxicity or mortality occurred. Very slight to well-defined eryteha (grade 1 to 2) and very slight edema (grade1) were observed. The dermal LD50 was greater than 2000 mg/kg b.w. (BASF SE 2013)

In accordance with column 2 of REACH Annex VIII, no acute inhalation toxicity study was conducted as two other routes are provided.

Justification for classification or non-classification

Based on the results of the available studies, Propylidynetrimethanol, ethoxylated, propoxylated, esters with acrylicacid, reaction products with 1-Butanamine, N-butyl- (> 1 <6.5) is not required to be classified for its acute toxicity potential according to 67/548/EEC and CLP/EU-GHS requirements.