Myrac Aldehyde

Endpoint summary

Description of key information

Acute toxicity, dermal in rats: LD50 > 2000 mg/kg bw (OECD 402, GLP, K, Rel.1)

Acute toxicity, oral in rats: LD50 > 5000 mg/kg bw (equivalent to OECD 401, K, Rel. 2)

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:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been followed but not GLP.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no details on test material (purity not indicated), no details on test animals and environmental conditions

GLP compliance:

no

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:

TEST ANIMALS
No details.
ENVIRONMENTAL CONDITIONS
No details.

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

No details.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 (no sex specified)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data

Statistics:

Not performed.

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

Slight lethargy was observed.

Body weight:

No data.

Dose mg/kg bw	No. of deaths	Observation day
		1	2	3	4	5	6	7	8	9	10	11	12	13	14
5000	0/10	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Interpretation of results:

other: Not acute harmful.

Remarks:

According to Regulation (EC) No. 1272/2008 and its amendments.

Conclusions:

An LD50 of >5000 mg/kg bw was determined in the acute oral toxicity study with rats.

Executive summary:

In an acute oral toxicity study one group of 10 rats was orally exposed to 5000 mg/kg bw of the substance. The rats were observed for signs of toxicity and clinical signs for a period of 14 days.

No deaths occurred and slight lethargy was observed among the animals.

Based on the results, an LD50 of >5000 mg/kg bw was determined in the acute oral toxicity study with rats.

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:

17-31 May 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP study performed according to OECD Guideline 402 without any deviation

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

dated 24 February 1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

dated 30 May 2008

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

23 October 2015

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER LABS, France
- Females (if applicable) nulliparous and non-pregnant: Not precised
- Age at study initiation: 7 or 8 weeks
- Weight at study initiation: 249-264 g (males); 208-220 g (females)
- Housing: On Day 1 of the study, animals were housed by group of five in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. During the treatment, the animals were kept in individual cages.
- Diet (e.g. ad libitum): Foodstuff (SAFE - A04), ad libitum
- Water (e.g. ad libitum): Drinking water (tap-water from public distribution system), ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25°C
- Humidity: 30-70%
- Air changes: At least 10/hour
- Photoperiod: 12 hours dark / 12 hours light

Type of coverage:

other: Non-occlusive porous gauze

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal area of the trunk (50 mm X 50 mm)
- % coverage: At least 10% of the body surface area
- Type of wrap if used: Animals from treated groups received the topical application of the test material under non occlusive porous gauze dressing (50 mm x 50 mm non-woven swab of 4-layer patch from MEDISTOCK) secured in position with a strip of surgical adhesive tape (50 mm wides hypoallergenic microporeTM adhesive tape from 3M).

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours
- Washing (if done): After removal of the gauze dressings, the treated area was rinsed with distilled water.


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.15 mL/kg bw (according to the density of 0.931 g/mL)

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: historical control

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations and mortality were recorded at 1 hour, 3 hours, 5 hours, and then once daily for 14 days. Animals were weighed on Day D0 (just before administering the test item) and then on Day 2, Day 7, and Day 14.
- Necropsy of survivors performed: Yes; animals were euthanized with sodium pentobarbital on Day 14 and macroscopic observations were noted.

Statistics:

No data

Preliminary study:

Not applicable

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Erythema was noted in all animals at 24-hour post-dose and was totally reversible on Day 6. Oedema was noted in maes at 24 hours post dose.

Mortality:

No mortality occurred during the study.

Clinical signs:

No systemic clinical signs related to the administration of the test substance were observed.

Body weight:

Body weight gain of the animals remained normal throughout the study.

Gross pathology:

The macroscopic examination of the animals at the end of the study did not reveal any treatment-related changes.

Other findings:

Erythema was noted in all animals at 24-hour post-dose and was totally reversible on Day 6.
Oedema was noted in maes at 24 hours post dose.

None

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the dermal LD50 of the test substance is >2000 mg/kg bw in rats therefore it is not classified according to the Regulation (EC) N° 1272-2008. No signal word or hazard statement is required.

Executive summary:

In an acute dermal toxicity study performed according to the OECD Guideline 402 and in compliance with GLP, a single dose of 2000 mg/kg bw of the test substance was applied onto the intact skin of 5 male and 5 female Sprague Dawley rats under occlusive conditions for 24 hours. Animals were then observed for mortality, dermal reactions, body weight changes and clinical signs of toxicity for 14 days.

No mortality occurred during the study. No systemic clinical signs related to the administration of the test substance were observed. Erythema was noted in all animals at 24-hour post-dose and was totally reversible on Day 6. Body weight gain of the animals remained normal throughout the study. The macroscopic examination of the animals at the end of the study did not reveal any treatment-related changes.

Rat Dermal LD50 >2000 mg/kg bw.

Under the test conditions, the dermal LD50 of the test substance is >2000 mg/kg bw in rats therefore it is not classified according to the Regulation (EC) N° 1272-2008 . No signal word or hazard statement is required.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP study conducted according to OECD TG 402

Additional information

Acute dermal toxicity:

In an acute dermal toxicity study performed according to the OECD Guideline 402 and in compliance with GLP, a single dose of 2000 mg/kg bw of the test substance was applied onto the intact skin of 5 male and 5 female Sprague Dawley rats under occlusive conditions for 24 hours. Animals were then observed for mortality, dermal reactions, body weight changes and clinical signs of toxicity for 14 days. No mortality occurred during the study. No systemic clinical signs related to the administration of the test substance were observed. Erythema was noted in all animals at 24-hour post-dose and was totally reversible on Day 6. Oedema was noted in males at 24 hours post dose. Body weight gain of the animals remained normal throughout the study. The macroscopic examination of the animals at the end of the study did not reveal any treatment-related changes. Rat Dermal LD50 >2000 mg/kg bw.

Acute oral toxicity:

In an acute oral toxicity study one group of 10 rats was orally exposed to 5000 mg/kg bw of the substance. The rats were observed for signs of toxicity and clinical signs for a period of 14 days.

No deaths occurred and slight lethargy was observed among the animals.

Based on the results, an LD50 of >5000 mg/kg bw was determined in the acute oral toxicity study with rats.

Justification for classification or non-classification

The oral and dermal LD50 are respectively higher than 5000 mg/kg bw and higher than 2000 mg/kg in rats, therefore the registered substance does not need to be classified for acute toxicity according to CLP Regulation (EC) n° 1272/2008.