Reaction Mass of 2,6-dimethyloct-7-en-2-ol and 2,6-dimethyloct-7-en-2-yl formate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Minimal experimental detail and documentation. Information available in a summary document only. Although studies were not conducted according to currently accepted protocols and did not follow GLP procedures, the studies followed acceptable procedures of the time and the results are valid.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction Mass of 2,6-dimethyloct-7-en-2-ol and 2,6-dimethyloct-7-en-2-yl formate

EC Number:

915-335-6

Molecular formula:

C11H20O2 C10H20O

IUPAC Name:

Reaction Mass of 2,6-dimethyloct-7-en-2-ol and 2,6-dimethyloct-7-en-2-yl formate

Test material form:

liquid

Test animals

Species:

rat

Administration / exposure

Route of administration:

oral: unspecified

Doses:

2560, 3200, 4000 or 5000 mg/kg bw

No. of animals per sex per dose:

10

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

4 100 mg/kg bw

95% CL:

>= 3 500 - <= 4 800

Mortality:

See Table 1.

Clinical signs:

other: 2.56 g/kg: lethargy 3.2 g/kg: lethargy, piloerection, blood on nose 4.0 g/kg: lethargy, flaccid, ataxia 5.0 g/kg: diarrhea

Gross pathology:

See "Table 2"

Any other information on results incl. tables

Table 1: Acute Oral Toxicity in the Rat - Mortality

Dose Levels (g/kg bwt)	Mortality, total	Day of Death
		0	1	2	3	6	9	11
2.56	1/10							1
3.2	3/10		2		1
4.0	4/10		2	1
5.0	8/10	1	5	2

Table 2: Acute Oral Toxicity in the Rat - Necropsy Findings

	Dose Levels (at death/sacrifice)
	2.56	2.56	3.2	3.2	4.0	4.0	5.0	5.0
Necropsy Observations	Death	Sacr	Death	Sacr	Death	Sacr	Death	Sacr
Normal		3		1
Exudate, nose/mouth					3		7
Lungs - dark			1
white nodules					2
dark areas			2	4		6	6	2
Liver - dark	1			1	1		4
mottled		3			2	2	3
Kidneys - dark				2
mottled		1
Skin - edema
hairless
Intestines - red areas			2		3		6
orange areas			1		1		1
Stomach - red areas			2	3
Spleen - large		2			2		1
dark						1

Applicant's summary and conclusion

Interpretation of results:

other: not acute harmful

Remarks:

according to EU CLP Regulation (EC) No. 1272/2008 and its amendments.

Conclusions:

The acute oral toxicity test showed an LD50 of 4100 mg/kg bw. The substance does needs to be classified as Acute Tox. 5 (H303) according to GHS.

Executive summary:

In an acute oral toxicity study performed similar to OECD 401 (pre-OECD and GLP), 10 rats were administered the test substance orally at dose levels of 2560, 3200, 4000 or 5000 mg/kg bw. The animals were observed for mortality and clinical signs for 14 days. Necropsy was performed after 14 days. Mortality was observed at all dose levels. Clinical signs included lethargy, piloerection, blood on nose, flaccid, ataxia and diarrhea. Necropsy findings included white nodules and dark areas in the lung, mottled and dark liver and kidneys, orange-red areas in the stomach and intestines and dark or enlarged spleen. The acute oral LD50 for the test substance in rats was determined to be 4100 mg/kg bw.