2,5,8,11-tetramethyldodec-6-yne-5,8-diol

Endpoint summary

Description of key information

According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.1 no classification required, since this substance does not cause concern of acute toxicity. 

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:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

no guideline available

Principles of method if other than guideline:

Five groups of five male albino rats of the Sherman-Wistar
Strain weighing between 200 and 300 gm were employed in
this study. The rats were deprived of food but not water
for 24 hours prior to dosing. Each animal was weighed and
dosed by direct administration of the experimental material
into the stomach by means of a syringe and dosing needle.

GLP compliance:

not specified

Remarks:

test done before GLP was established

Test type:

fixed dose procedure

Limit test:

no

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Each animal was dosed by direct administration of the experimental material
into the stomach by means of a syringe and dosing needle.

Doses:

1 g/kg
2 g/kg
4 g/kg
8 g/kg
16 g/kg

No. of animals per sex per dose:

five animals (males) per dose

Control animals:

no

Details on study design:

Five groups of five male albino rats of the Sherman-Wistar
Strain weighing between 200 and 300 gm were employed in
this study. The rats were deprived of food but not water
for 24 hours prior to dosing. Each animal was weighed and
dosed by direct administration of the experimental material
into the stomach by means of a syringe and dosing needle.

Statistics:

The subject material when studied in male albino rats has
an acute oral LD of 12.9 gm/kg. with 19/20 Confidence
~imits of from 8?8 to 20.1 gm/kg.

Sex:

male

Dose descriptor:

LD50

Effect level:

12 900 mg/kg bw

Based on:

test mat.

95% CL:

> 8 400 - < 20 100

Mortality:

one animal within 24 hours in the 8 g group
one animal within 24 hours and two within 48 hours in the 16 g group

Clinical signs:

other: At the dosage levels of 1.0 and 2.0 gm/kg. the animals were ruffled, dirty and slightly depressed after 24 hours. They appeared recovered and normal after 48 hours. At the dosage level of 4.0 gm/kg. the animals were depressed after 4-6 hours. Within 24 ho

Gross pathology:

In the gross pathologic examination, slight hemorrrhaging of the GI tract was evident in those animals dying during
the course of the study. Gross pathologic examination of the animals sacrificed a t the conclusion of the observation
period revealed nothing remarkable.

Dosage Level g/kg	Number of Animals Dosed	1	2	3	4	5	6	7	8	9	10	11	12	13	14	Total Dead 14 Days	Total Survived 14 Days	Average Initial Weight [g]	Average Final Weight [g]
1.0	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	235	280
2.0	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	220	250
4.0	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	240	275
8.0	5	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	4	210	235
16.0	5	1	2	0	0	0	0	0	0	0	0	0	0	0	0	3	2	220	245

Interpretation of results:

GHS criteria not met

Conclusions:

The subject material when studied in male albino rats has an acute oral LD50 of 12.9 gm/kg. with 9/20 Confidence limits of from 8.4 to 20.1 gm/kg.

Executive summary:

The subject material when studied in male albino rats has an acute oral LD50 of 12.9 mg/kg. with 19/20 Confidence limits of from 8.4 to 20.1 gm/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

12 900 mg/kg bw

Quality of whole database:

Study has been done before the establishment of GLP, but is supported by a study on a category member which is following the Guide to Precautionary Labeling of Hazardous Chemicals, Seventh Edition - 1970, published by the Manufacturing Chemist´s Association. Klimisch score 2.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

no guideline followed

Principles of method if other than guideline:

One group of ten (5 male and 5 female) albino rats was used in this study. The rats were placed in a 70 liter, all glass exposure chamber and exposed to a saturated atmosphere of the test material in air for one hour. The material was administered as an aerosol. the material was heated gently to approximately 135°F (57°C) to facilitate aerosolizing. The rate of flow was 10.0 liters per minute at a temperature of 70°F (21°C). The air was passed threough a desicant prior to being passed through the test material. By differential weighing it was calculated that the rats were subject to concentration of 20.1 mg/liter during the exposure period. This is an average value over the one hour period.

GLP compliance:

no

Species:

rat

Strain:

other: albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

5 male & 5 female albino rats

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Chamber
- Exposure chamber volume: 70 liter

Analytical verification of test atmosphere concentrations:

yes

Remarks:

differential weighing

Duration of exposure:

14 d

Concentrations:

20.1 mg/liter

No. of animals per sex per dose:

5 male and 5 female

Control animals:

no

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 20.1 mg/L air (nominal)

Mortality:

none

Clinical signs:

other: Immediately after exposure the animals were ruffled, wheezing and dirty. Within 24 hours they appeared recovered and normal.

Body weight:

Average initial weight: 210 gr males and 205 gr females
Average final weight: 255 gr males and 230 gr females

Gross pathology:

Gross pathologic examination revealed nothing remarkable.

total dead 14 days:       0

total survived 14 days: 10 (all)

Interpretation of results:

GHS criteria not met

Conclusions:

From the results obtained in this study using the method described above, it appears that the subject material has an LC50 greater than 20.1 mg/liter, the maximum concentration which could attained.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

20 000 mg/m³ air

Quality of whole database:

Study has been done before the establishment of GLP, but is supported by a study on a category which member following the Guide to Precautionary Labeling of Hazardous Chemicals, Seventh Edition - 1970, published by the Manufacturing Chemist´s Association. Klimisch score 2.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: Section 173.240 (a) (1) and Appendix A

Principles of method if other than guideline:

One group of six (3 male and 3 female) albino rabbits weighing between 2.0 and 3.0 kg each was employed in this study. All animals had their back clipped free of hair 24 hours prior to testing. All of the animals had their backs abraded prior to dosing.
The sample was dosed as supplied.
The following dosage level was administered: 1.0 mg/kg.
All rabbits were weighted and the correct amount of experimental material was applied to the back of each animal. These treated areas were covered with large gauze patches and an impervious material was wrapped snugly around the trunk of each animal. The dressings were removed after twenty-four hours and any excess material was removed and the approximate amount remaining was noted. The animals were observed for a 14 day period for signs of toxicity and for mortalities. Gross autopsies were performed onall animals which died during the 14 day observation period and also on all survivors of the 14 day observation period.

GLP compliance:

no

Test type:

fixed dose procedure

Species:

rabbit

Strain:

other: albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

3 males and 3 females

Type of coverage:

other: gauze patches for 24 hours

Vehicle:

other: none

Details on dermal exposure:

24 hours

Duration of exposure:

24 hours

Doses:

1.0 gr/kg bw

No. of animals per sex per dose:

3 male
3 female

Control animals:

no

Preliminary study:

no prelimenary study

Sex:

male/female

Dose descriptor:

other: corrosion

Effect level:

> 1 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: very slight edema and erythema

Interpretation of results:

study cannot be used for classification

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 1 mg/kg bw

Quality of whole database:

Study has been done before the establishment of GLP, but is supported by a study on a category member which meets the criteria set forth in Regulation EC No. 440/2008 for filling REACH endpoints and is of high quality, Klimisch score = 1. The data is generated in a reliable laboratory using established protocols. This data valid as documented CCRF for this category (Acetylenic geminalic diols).

Additional information

There is no data gap.

According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.1 no classification required, since this substance does not cause concern of acute toxicity.

Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for selection of acute toxicity – inhalation endpoint
Only one study available.

Justification for selection of acute toxicity – dermal endpoint
Only one study available.

Justification for classification or non-classification

According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.1 no classification required, since this substance doese not cause concern of acute toxicity.