N-(2-ethoxyphenyl)-N'-(4-isododecylphenyl)oxamide

Endpoint summary

Description of key information

Acute toxicity after single oral application was tested in male and female rats, which received up to 10,000 mg/kg bw. No animal died or showed clinical symptoms/macroscopic anomalies. The necropsy did not reveal any effect. The LD50 value for acute oral toxicity was considered to be greater than 10,000 mg/kg bw. Due to the findings described above (LD50 oral in rats greater than 10,000 mg/kg bw) Hostavin 3206 does not have to be classified as acute orally toxic.

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:

23. Feb - 26. March 1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well performed and reported study equivalent to OECD guideline 401.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

4 days acclimatisation

GLP compliance:

no

Remarks:

performed before GLP guidelines

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS (Wistar Hannover KFM)
- Source: Kleintier-Farm Madoerin AG, Füllinsdorf, Switzerland
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 170-220 g
- Fasting period before study: overnight
- Housing: in groups of 5 (males respectively females) in Macrolon cages (type III)
- Diet (e.g. ad libitum): Standard Kliba 343 Rat Maintenance Food (Klingentalmühle, Switzerland), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2°C
- Humidity (%): 55+/-10%
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

Before treatment the suspension (in PEG 400) was homogeneously dispersed with an ultra-turrax and during treatment was kept stable with a magnetic stirrer.

Doses:

5000 mg/kg bw
7000 mg/kg bw
10000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily clinical observations after application / weighing once weekly
- Necropsy of survivors performed: yes

Statistics:

LD50 including 95 % confidence limits are calculated by the Logit Model.

Preliminary study:

None

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Remarks on result:

other: no effects

Mortality:

no deaths occurred

Clinical signs:

other: no significant effects

Gross pathology:

no macroscopic findings

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose of Hostavin 3206 (LD50) was > 10000 mg per kg body weight. Based on the result of this study Hostavin 3206 is not subject for labelling and classification requirements according to regulatory requirements.

Executive summary:

The acute oral LD50 of Hostavin 3206 in rats of both sexes observed over a period of 14 days is > 10000 mg/kg.

Based on the result of this study Hostavin 3206 is not subject for labelling and classification requirements according to regulatory requirements.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 000 mg/kg bw

Quality of whole database:

reliable without restrictions

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:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

 Based on the results of an oral toxicity study the LD50 value for acute oral toxicity was considered to be greater than 10,000 mg/kg bw.

In accordance with REACH “Column 2” in Annex VIII there is sufficient weight of evidence from several independent sources of information leading to the conclusion that Hostavin 3206 does not exert systemic toxic effects after acute inhalation exposure and thus does not have to be classified, because
- the LD50 value for acute oral toxicity of Hostavin 3206 is greater 10,000 mg/kg bw,
- Hostavin 3206 does not have to be classified as skin irritating,
- inhalation to consumer is very unlikely to occur, since the substance is embedded in polymeric matrices for consumer applications and
-inhalation exposure to workers while manufacturing is also considered to be negligible with reference to the physical state (viscous liquid) and low volatility (2.8 hPa) of this substance.
Therefore, it is concluded that testing of acute inhalation toxicity of Hostavin 3206 salt is not scientifically necessary.

It can reasonably be deduced that Hostavin 3206 does not exert systemic toxic effects after dermal application and thus does not have to be classified, because this substance did not cause lethal effects after administration of a single oral dose of up to 10,000 mg/kg bw in rats.Furthermore the substance does not have to be classified as skin irritating. Due to the combination of its polar character (amine and carbonyl function at one end of the molecule) and the long extent of the alkyl chain (at the other end of the molecule) it is unlikely that higher amounts (limit dose of dermal toxicity testing according OECD 402: 2,000 mg/kg bw/d) than tested in the acute oral toxicity study (tested up to 10,000 mg/kg bw/d) will be systemically available via the intact skin barrier even if the most unlikely amount of 100% penetration is assumed. Therefore, testing is not scientifically necessary.

Justification for selection of acute toxicity – oral endpoint
Well performed and reported study equivalent to OECD guideline 401.

Justification for selection of acute toxicity – inhalation endpoint
n.a.

Justification for selection of acute toxicity – dermal endpoint
n.a.

Justification for classification or non-classification

Due to the findings described in the acute oral toxicity study (LD50 oral in rats greater than 10,000 mg/kg bw) Hostavin 3206 does not have to be classified as acute orally toxic. Based on the substance's physico-chemical and non-irritant properties, as well as the unlikeliness of exposures to consumer and workers no higher systemical exposure via inhalation or dermal penetration is expected to occur than that tested in the course of the oral toxicity study. Therefore, Hostavin 3206 does not have to be classified as acute toxic.