Registration Dossier

Administrative data

Description of key information

Acute oral toxicity (OECD 423): LD50 (rat, f) > 2000 mg/kg bw

Acute dermal toxicity (OECD 402): LD50 (rat, m/f) > 2000 mg/kg bw

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:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom, GLP Monitoring Authority, UK
Test type:
acute toxic class method
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Bantin & Kingman, Hull, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 169 - 186 g
- Housing: Groups of 3 in suspended solid floor polypropylene cages with woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 and 14 day
- Necropsy of survivors performed: yes
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
On the day of dosing and up to 24 h after dosing: hunched posture, lethargy, ataxia, decreased respiratory rate, ptosis, occasional body tremors, laboured respiration, exophthalmos and piloerection. All animals appeared normal two days after dosing.
Body weight:
All animals showed expected gains in body weight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.

Additional data supporting the information is attached below under 'Attached background material'.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
The acute oral LD50 in the female Sprague-Dawley CD strain rat was determined to be > 2000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable (Klimisch score 1) study performed with the registered substance. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, Section 8.5., of Regulation (EC) No. 1907/2006.

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:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom, GLP Monitoring Authority, UK
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Bantin & Kingman, Hull, UK.
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: least 200 g
- Housing: Individually during exposure and in groups of 5 by sex for the remainder of the study period
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Shorn skin
- % coverage: approx. 10% of the total body surface area
- Type of wrap if used: Self adhesive bandage

REMOVAL OF TEST SUBSTANCE
After the 24 h contact period, treated skin and surrounding hair were wiped with distilled water.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths occurred.
Clinical signs:
No signs of systemic toxicity were observed.
Body weight:
Animals showed the expected gains in body weight over the study period.
Gross pathology:
No abnormalities were noted on necropsy.

Additional data supporting the information is attached below under 'Attached background material'.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
The acute dermal LD50 in the Sprague-Dawley CD strain rat was found to be > 2000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable (Klimisch score 1) study performed with the registered substance. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII, Section 8.5., of Regulation (EC) No. 1907/2006.

Additional information

Acute oral toxicity

The acute oral toxicity of propylidentrimethanol, propoxylated (CAS No. 25723-16-4, EC No. 500-041-9) was investigated in a study conducted according to OECD guideline 423 under GLP conditions (rel 1-key, rat, OECD 423, Safepharm, 2002a, 1691/004). A group of three fasted Sprague-Dawley CD strain rat females was treated with the test substance at a dose level of 2000 mg/kg bw. This was followed by a further group of three fasted females at the same dose level. The test material was administered by gavage as a solution in distilled water. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. The study period was 14 days. All animals survived until scheduled necropsy. Signs of systemic toxicity noted were hunched posture, lethargy, ataxia, decreased respiratory rate, ptosis, occasional body tremors, laboured respiration, exophthalmos and piloerection. All animals appeared normal two days after dosing and showed the expected gains in body weight over the study period. No abnormalities were noted at necropsy. The acute oral LD50 of propylidentrimethanol, propoxylated in the female Sprague-Dawley CD strain rat was determined to be > 2000 mg/kg bw.

Acute dermal toxicity

A study according to OECD guideline 402 and following GLP conditions was performed to investigate the acute dermal toxicity of propylidentrimethanol, propoxylated (CAS No. 25723-16-4, EC No. 500-041-9) (rel 1-key, rat, OECD 402, Safepharm, 2002b, 1691/005). Groups of 5 male and 5 female Wistar (HsdCpb:Wu) rats received a single dose of 2000 mg/kg bw of the unchanged test substance applied onto the skin under semi-occlusive conditions for 24 h. Animals were observed for 14 days post application. No deaths occurred and no clinical signs of systemic toxicity were observed. Animals showed the expected gains in body weight over the study period. At necropsy, no abnormalities were noted in all animals. The dermal acute LD50 was, therefore, determined to be > 2000 mg/kg bw.

Justification for classification or non-classification

The available data on oral and dermal acute toxicity with propylidentrimethanol, propoxylated (CAS No. 25723-16-4, EC No. 500-041-9) do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP) and are therefore conclusive but not sufficient for classification.