Alcohols, C6-8, ethoxylated

Endpoint summary

Description of key information

There are no human data on acute toxicity for the registered substance. In animals, test results with this compound are available for the oral route of exposure indicating LD50 values of greater 2000 mg/kg body weight for this exposure routes. As inhalation is not an exposure route of major concern and LD50 value for acute oral toxicity is greater than 2000 mg/kg body weight indicative of a very low acute systemic toxic potential, no experimental studies have been performed using the inhalation route of exposure.

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

Study period:

1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

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: Hoechst AG, Kastengrund, SPF Breeding
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation:
- Fasting period before study: approximately 16 hours
- Housing: Makrolon cages (typ 4)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours

Route of administration:

oral: gavage

Vehicle:

water

Doses:

2000 mg/kg body weight (limit dose)

No. of animals per sex per dose:

5 animals per sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000

Based on:

test mat.

Remarks on result:

other: no lethality

Mortality:

No mortalities throughout study period

Clinical signs:

other: squatted posture up to 6 hours after treatment no clinical signs from day 1 until end of the study

Gross pathology:

no macroscopical visible changes

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 in rats of the registered substance is greater than 2000 mg/kg body weight limit dose) and thus the test material is not subjecz for labelling requirements.

Executive summary:

Flotanol F was tested for acute oral toxicity in male and female Wistar rats rats. After application of 2000 mg/kg body weight by gavage no deaths occurred within the subsequent observation period of 14 days. At this limit dose some unspecific clinical symptoms like sqatted posture were observed which, however, were reversible within the first 24 hours after application. Macroscopically visible changes were not observed during necropsy. Based on the results of this study the median lethal dose (LD50) of Flotanol F in the rat is greater than 2 000 mg/kg body weight

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Guideline study according to GLP available. No derivations and/or confounders. Klimisch rating 1 indicates reliability without restrictions. Information valid and meets data requirements.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There are no human data on acute toxicity for the registered substance available. In animals, however, this substance was tested for acute oral toxicity in male and female Wistar rats according to OECD test guidelines 401. After application of 2000 mg/kg body weight by gavage no deaths occurred within the subsequent observation period of 14 days. At this limit dose only minor unspecific clinical symptoms like squatted posture were observed which, however, were reversible within the first 24 hours after application. Macroscopically visible changes were not observed during necropsy. Based on the results of this study the median lethal dose (LD50) of the registered substance in the rat is greater than 2 000 mg/kg body weight. Likewise, also topical exposure of the registered substance to male and female rats under occlusive conditions in an acute dermal toxicity study according to OECD guideline 402 revealed a median lethal dose (LD50) of greater 2000 mg/kg body weight. No data concerning acute inhalation toxicity is available.

Justification for selection of acute toxicity – oral endpoint
Guideline study according to GLP with a Klimisch rating 1

Justification for selection of acute toxicity – inhalation endpoint
Waiving for scientific reasons as specified in the ECHA guidance on information requirements and chemical risk assessment, chapter R.7a (endpoint specific guidance, R.7.4.6.3) since both, an acute oral toxicity study as well as an acute dermal toxicity study are available and no systemic effects have been observed. Inhalation is not an exposure route of major concern and the formation of inhalable particle sizes and/or aerosols can be excluded.

Justification for selection of acute toxicity – dermal endpoint
Waiving for scientific reasons since there is no indication of acute toxicity after oral application and no sign of systemic toxicity in an in vivo skin irritation study. This is in concordance with REACH Annex VIII 8.5.3.

Justification for classification or non-classification

Based on the available LD50 values of greater 2000 mg/kg body weight for both, the acute oral toxicity and acute dermal toxicity studies, the registered substance is not subject for labelling and classification requirements neither according DSD not GHS/CLP. For acute inhalation toxicity, no data is available. However, since the available data do not point to an acute systemic toxic potential of the registered substance and inhalation is also no exposure route of major concern, no classification for this endpoint is deducible.