Decan-4-olide

Endpoint summary

Description of key information

- Acute toxicity: oral: LD50 > 2000 mg/kg bw (WoE)
- Acute toxicity: dermal: LD50 > 2000 mg/kg bw/f (WoE)
- Acute toxicity: inhalation: waiving

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:

weight of evidence

Study period:

1975

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Only short abstract available. No certificate of analysis of the test item.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no details on test animals and environmental conditions; no details on results

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

None

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

None

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

Total animals: 10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

None

Preliminary study:

Not applicable

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

One animal died on Day 1

Clinical signs:

other: Slight letargy was noticed

Gross pathology:

No data

Other findings:

None

None

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 of γ-Decalactone is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Annex VI of the Directive 67/548/EEC and of the Regulation (EC) N° 1272-2008 (CLP).

Executive summary:

In an acute oral toxicity (limit test) study, a group of 10 rats were given a single oral dose of γ-Decalactone at 5000 mg/kg bw. Animals were then observed for 14 days.

During the observation period, slight lethargy was noticed and one animal died on Day 1.

Oral LD50 > 5000 mg/kg bw in rats.

The oral LD50 of γ-Decalactone is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the Regulation (EC) N° 1272-2008 (CLP).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The available information as a whole meets the tonnage driven data requirement of REACH. Moreover, reliability and consistency are observed across the different studies.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The available information as a whole meets the tonnage driven data requirement of REACH. Moreover, reliability and consistency are observed across the different studies.

Additional information

Acute toxicity: oral

Due to the poor description of the only study conducted on γ-Decalactone, a weight of evidence approach was used to evaluate its acute oral toxicity. This approach is based on the similarity between aliphatic γ-lactones (see §"Toxicokinetics" for read-across justification).

In the γ-Decalactone study (Moreno, 1975, rel.4), rats were given a single dose of test material and observed for 14 days. The oral LD50 was higher than 5000 mg/kg bw/d. However, the protocol and results were poorly reported and the substance purity was not mentioned. Therefore, the result was not considered sufficiently robust and read-across data were required to conclude on acute oral toxicity.

The combined LD50 of γ-Caprolactone was higher than 2000 mg/kg bw in a limit test performed similarly to the OECD test guideline No. 420 (Sunaga, 2002, rel. 2). In the same way, the male LD50 of γ-Nonalactone was calculated to be 6600 mg/kg bw in an OECD 401 study (Moreno, 1972, rel.2).

Based on all available data, the acute oral LD50 value was considered to be higher than 2000 mg/kg bw and to be a worst-case for the hazard assessment purpose.

Acute toxicity: dermal

Due to the poor description of the only study conducted on γ-Decalactone, a weight of evidence approach was used to evaluate its acute dermal toxicity profile. This approach is based on the similarity between aliphatic γ-lactones (see §"Toxicokinetics" for read-across justification).

In the the γ-Decalactone study (Moreno, 1975, rel.4), rabbits were administered a single dermal dose of the test material and were observed for 14 days. The dermal LD50 was higher than 5000 mg/kg bw. No mortality was observed during the observation period. Slight redness (2/10), moderate redness (8/10), slight edema (1/10) and moderate edema (9/10) were noticed. However, the protocol and results were poorly reported and the substance purity was not mentioned. Therefore, the result was not considered sufficiently robust and read-across data were required to conclude on acute dermal toxicity.

The dermal LD50 of γ-Nonalactone was higher than 5000 mg/kg bw based on two limit acute dermal studies (Moreno, 1973, rel.3 & Levenstein, 1976, rel.4) and the dermal LD50 of γ-Undecalactone was higher than 2000 in an OECD 402 & GLP study (Sanders, 1999, rel.2).

Based on all available data, the acute dermal LD50 value was considered to be higher than 2000 mg/kg bw and to be a worst-case for the hazard assessment purpose.

Acute toxicity: inhalation

No data was available. However, in accordance with column 2 of REACH Annex VIII (§8.5), the acute toxicity by inhalation does not need to be conducted since the acute toxicity study is already provided for both the oral and the dermal routes. Moreover, γ-Decalactone has a low vapor pressure (0.72 Pa at 25 °C) and therefore the potential for the generation of an inhalable form is low.

Justification for selection of acute toxicity – oral endpoint
Due to the poor description of the only study conducted on γ-Decalactone, a weight of evidence approach was used to evaluate its acute oral toxicity based on the similarity between aliphatic γ-lactones (see §"Toxicokinetics" for read-across justification).

Justification for selection of acute toxicity – inhalation endpoint
In accordance with column 2 of REACH Annex VIII (§8.5), the acute toxicity by inhalation does not need to be conducted since the acute toxicity study is already provided for both the oral and the dermal route.

Justification for selection of acute toxicity – dermal endpoint
Due to the poor description of the only study conducted on γ-Decalactone, a weight of evidence approach was used to evaluate its acute dermal toxicity profile based on the similarity between aliphatic γ-lactones (see §"Toxicokinetics" for read-across justification).

Justification for classification or non-classification

Harmonized classification:

γ-Decalactone has no harmonized classification according to the Regulation (EC) No. 1272/2008 including ATP2.

Self classification:

Based on the available data no additional self-classification is proposed regarding:

- both acute oral and dermal toxicity and,

-specific target organ toxicity -single exposure

according to the Regulation (EC) No. 1272/2008 (CLP) and of the Directive 67/548/EEC. No data were available by inhalation.