Undecanal

Endpoint summary

Description of key information

The LD50 for acute oral toxicity is given as > 5000 mg/kg bw (Ruhrchemie AG/Safepharm, 1985; RL2, rat). For acute dermal toxicity a  LD > 5000 mg/kg bw  was determined (Shelanski and Moldovan, 1971; RL2, rabbit).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

From 12 FEB 1985 to 6 MAR 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given: comparable to guidelines

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

: substance composition or purity not stated

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

No information on purity provided, but it can reasonably be assumed that the test substance has a typical composition of 67% n-undecanal and 31% iso-undecanal as the substance was produced under comparable conditions of todays substance.

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: A. Tuck & Sons Limited, Battlesbridge, UK
- Age at study initiation: 4 to 6 weeks
- Weight at study initiation: males: 128-146 g, females: 127-139 g
- Fasting period before study: overnight
- Housing: in polypropylene cages with sawdust bedding in groups of five by sex
- Diet: standard laboratory rodent diet (Rat & Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 40-50
- Air changes (per hr): ~10
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 6.08 mL/kg

Doses:

5000 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: 0.5, 1, 2, 3, 4 and 5 hours following dosing; on subsequent days at least once
- Frequency of weighing: weekly (on day 0, 7, 14)
- Necropsy of survivors performed: yes

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: no animal died within the observation period

Mortality:

- no deaths occurred

Clinical signs:

other: - shortly after dosing: abnormal body carriage (hunched posture), lethargy, pilo-erection and a decreased respiratory rate - in some animals: diarrhoea and ptosis - recovery of all rats complete at day 3 (judged by external appearance and behaviour)

Gross pathology:

- in three rats congestion of the lungs only
- no macroscopic abnormalities seen in any of the remaining rats

Interpretation of results:

GHS criteria not met

Conclusions:

Under the tested conditions, the substance did not reveal acute oral toxicity, no mortality occurred in rats which received a single dose of 5000 mg/kg bw.

Executive summary:

The test item (purity: not stated) was administered to 5 male and 5 female Sprague-Dawley albino rats by gavage at the limit dose of 5000 mg/kg bw according to testing guideline OECD 401. Following dosing minor clinical signs (as e.g. hunched posture, pilo-erection as well as diarrhoea or ptosis) occurred, but were all reversible within 3 days. During the 14 days observation period no animal died. Subsequent gross pathology revealed congestions of the lungs in three rats, but no other macroscopic changes were seen. The given results lead to a LD50 > 5000 mg test item per kg bw (Ruhrchemie AG/Safepharm, 1985).

This study was judged to be reliable with restrictions (RL2), due to missing information on substance composition and purity.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

assessment report

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Clinical signs:

other:

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the LD50 was > 5000 mg/kg bw

Executive summary:

The study used as source investigated a reaction mass of 2-methyldecan-1-al (iso-undecanal) and undecanal.The study results of the source compound were considered applicable to the target

compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 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

Study period:

October 1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given: comparable to guidelines

Qualifier:

according to guideline

Guideline:

other: Final Order, Enforcement Regulations (Fed. Register of August 12, 1961, Vol 26, No. 155, pages 7333-7341)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

other: albino

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2500 to 3500 g

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 10.7% of body surface
- Type of wrap if used: made of rubber dam

REMOVAL OF TEST SUBSTANCE
- Washing: after removal of sleeves by thorough wiping
- Time after start of exposure: up to 24 h

Duration of exposure:

up to 24 h

Doses:

5000 mg/kg

No. of animals per sex per dose:

6 (3 animals with intact skin, 3 animals with abraded skin)

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: no animals died within the 14 days observation period

Mortality:

no deaths occurred

Clinical signs:

other: dry and cracked skin noted

Gross pathology:

no data

Interpretation of results:

GHS criteria not met

Conclusions:

Under the tested conditions, the substance did not reveal acute dermal toxicity, no animal died after single dermal application of 5000 mg/kg bw.

Executive summary:

The test item (purity: not stated) was subjected to test acute dermal toxicity in albino rabbits. This study was conducted according to the requirements of Federal Register, 1961 (Vol 26, No. 155, pages 7333 -7341). The undiluted substance was applied at a limit dose of 5000 mg/kg bw onto the intact or abraded skin of the animals (3 animals per condition) for up to 24 h under occlusive conditions. During the 14 days observation period dry and cracked skin could be noted, but no animal died. The given results lead to a LD50 > 5000 mg test item per kg bw (Shelanski and Moldovan, 1971).

This study was judged to be reliable with restrictions (RL2), due to missing information on substance purity and the missing necropsy data.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Additional information

In a reliable study (RL2) the test item (purity: not stated) was administered to 5 male and 5 female Sprague-Dawley albino rats by gavage at the limit dose of 5000 mg/kg bw according to testing guideline OECD 401. Following dosing minor clinical signs (as e.g. hunched posture, pilo-erection as well as diarrhoea or ptosis) occurred, but were all reversible within 3 days. During the 14 days observation period no animal died. Subsequent gross pathology revealed congestions of the lungs in three rats, but no other macroscopic changes were seen. The given results lead to a LD50 > 5000 mg test item per kg bw (Ruhrchemie AG/Safepharm, 1985).

This observation was confirmed by another study (RL2), where oral adminsitration (gavage) of the test item (purity: not stated) to male and female rats resulted in a median lethal dose (LD50) of > 5000 mg/kg bw (Shelanski and Moldovan, 1971).

The test item (purity: not stated) was subjected to test acute dermal toxicity in albino rabbits. This reliable study (RL2) was conducted according to requirements of Federal Register, 1961 (Vol 26, No. 155, pages 7333 -7341). The undiluted substance was applied at a limit dose of 5000 mg/kg bw onto the intact or abraded skin of the animals (3 animals per condition) for up to 24 h under occlusive conditions. During the 14 days observation period dry and cracked skin could be noted, but no animal died. The given results lead to a LD50 > 5000 mg test item per kg bw (Shelanski and Moldovan, 1971).

Justification for classification or non-classification

Based on the LD50 of > 5000 mg/kg bw in experimental studies a classification for acute oral toxicity is not required according to Regulation (EC) No 1272/2008.

Based on the LD50 of > 5000 mg/kg bw in the key study no classification for acute dermal toxicity is required according to Regulation (EC) No 1272/2008.