1-(2-ethylbutyl)cyclohexanecarbonyl chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

other information

Study period:

September 26,2006 to December 11,2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

This study followed the procedures indicated by the following internationally accepted guidelines and recommendations: First Addendum to OECD Guidelines for Testing of Chemicals, Section 4, No. 423, “Acute Oral Toxicity - Acute Toxic Class Method” adopted December 17,2001 Directive 96/54 EEC B. 1 .tris. EPA Health Effects Test Guidelines, OPPTS 870.1100 “Acute oral toxicity”, EPA 7 12-C-02-190, December 2002 EPA Health Effects Test Guidelines, OPPTS 870.1000 “Acute toxicity testing background”, EPA 712-C-02-189, December 2002.

Data source

Reference

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

and EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-(2-ethylbutyl)cyclohexanecarbonyl chloride

EC Number:

619-547-7

Cas Number:

211515-46-7

Molecular formula:

C13 H23 Cl O

IUPAC Name:

1-(2-ethylbutyl)cyclohexanecarbonyl chloride

Details on test material:

Name: CAT-Acid chloride
CAS No.: 211515-46-7
Storage: refrigerator +2 to +8 degree C
Safety precautions: Routine hygienic procedures were sufficient
to assure personnel health and safety.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Carboxymethylcellulose (Sigma Chemicals Co., Lot llOKO199), 1% (w/v) in aqua ad inj.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

Three female animals

Control animals:

not specified

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

The acute toxic class method was performed with the test item CAT-Acid

chloride.

A careful clinical examination was made several times on the day of dosing.

Part of this were at least three observations within the first four hours postdose.

Animals were observed once a day thereafter.

In the first step the test item was given at a dose of 2000 mg/kg body weight

to a group of 3 female rats (HsdRccHan : WIST) in a single exposure via

oral gavage.

Animal No. 1 of step 1 showed slightly reduced spontaneous activity and

apathy 45 minutes post dose. 105 minutes post dose slightly reduced

spontaneous activity, half eyelid-closure, apathy, as well as piloerection were

recorded. 3 hours 15 minutes, 4 hours 45 minutes, as well as 6 hours 45

minutes post dose moderately reduced spontaneous activity, complete

eyelid-closure, apathy and piloerection were recorded. 1 day post dose until

the end of the observation period no signs of toxicity were observed.

Animal No. 2 of step 1 showed slightly reduced spontaneous activity and

apathy 40, as well as 100 minutes post dose. 3 hours 40 minutes post dose

slightly reduced spontaneous activity, half eyelid-closure, apathy, as well as

piloerection were recorded. 1 day post dose until the end of the observation

period no signs of toxicity were observed.

Animal No. 3 of step 1 showed slightly reduced spontaneous activity and

apathy 40 minutes, 100 minutes, as well as 3 hours 40 minutes post dose.

1 day post dose until the end of the observation period no signs of toxicity

were observed.

No other treatment related effect was observed in any animal of step 1.

In the second step the test item was given at the same dose and in the same

manner to a further group of 3 female rats (HsdRccHan : WIST).

No treatment related effect was observed in any animal of step 2.

Following the acute toxic class regime of OECD 423 no further testing was

required.

Beside acute injection of blood vessels in the abdominal region, which is due

to the euthanasia injection, no special gross pathological changes were found

in any animal of any step.

Throughout the 14-days observation period no weight loss was recorded in

any animal. The weight gain was within the expected range.

Therefore, according to OECD Guideline 423, a sufficient estimation of the

acute oral toxicity of the test item is provided.

Applicant's summary and conclusion

Interpretation of results:

sligthly toxic

Remarks:

Migrated information Considering the reported data of this toxicity test it can be stated that the test item CAT-Acid chloride showed slightly oral toxic characteristics. Criteria used for interpretation of results: OECD GHS

Conclusions:

Considering the reported data of this toxicity test it can be stated that the test
item CAT-Acid chloride showed slight oral toxic characteristics.
According to GHS (Globally Harmonized Classification System) the test
item CAT-Acid chloride was classified into Category 5 (LD50 cut-off:
unclassified).

Executive summary:

Title:

Acute Oral Toxicity, Acute Toxic Class Method with CAT-Acid chloride

 

Guidelines:

This study followed the procedures indicated by the following

internationally accepted guidelines and recommendations:

First Addendum to OECD Guidelines for Testing of Chemicals, Section 4,

No. 423, “Acute Oral Toxicity - Acute Toxic Class Method” adopted

December 17,2001

Directive 96/54 EEC B. 1 .tris.

EPA Health Effects Test Guidelines, OPPTS 870.1100 “Acute oral toxicity”,

EPA 7 12-C-02-190, December 2002

EPA Health Effects Test Guidelines, OPPTS 870.1000 “Acute toxicity

testing background”, EPA 712-C-02-189, December 2002.

Materials and Methods:

 

Preparation of the Test Item:

Vehicle: Carboxymethylcellulose (Sigma Chemicals Co., Lot ll0K0199), 1% (w/v) in aqua ad inj. (B. Braun Melsungen AG, Lot 6153A195)

For the first animal of the first step 1 g of the test item was dissolved in the

vehicle ad 5 mL and for the other animals of step 1, as well as for all animals

of the second step 2 g of the test item were dissolved ad 10 mL to gain a

concentration of 2000 mg/kg body weight.

The test substance was freshly mixed prior to administration and stirred

throughout dose administration to guarantee stability and homogeneity. The

vehicle was chosen due to its non-toxic characteristics.

 

Test Animals:

HsdRccHan : WIST rats (Full-Barrier), Sex: females, non-pregnant, nulliparous.

Step 1: Body weight at the commencement of the study: 171 - 179 g;

Step 2: Body weight at the commencement of the study: 143 - 155 g;

Three female animals were used for each step.

The animals were derived from a controlled full barrier maintained breeding

system (SPF).

Source: Harlan Winkelmann GmbH, D-33 178 Borchen.

According toArt.9.2, No.7 of the German Act on Animal Welfare the

animals were bred for experimental purposes.

Animal Husbandry:

The animals were barrier maintained (semi-barrier) in an air conditioned

room

Temperature: 22 +/- 3 degree C

Rel. humidity: 55 +/- 10%

Artificial light, sequence being 12 hours light, 12 hours dark

Air change: 10 x / hour

Feeding ad libitum, Altromin 1324 maintenance diet for rats and mice,

totally-pathogen-free (TPF)

Free access to tap water (drinking water, municipal residue control,

microbiol. controlled periodically)

The animals were kept in Macrolon cages on Altromin saw fiber bedding

Certificates of food, water and bedding are filed at BSL Bioservice

Adequate acclimatization period.

 

Preparation of the Animals:

The animals were marked for individual identification by tail painting.

Prior to the administration a detailed clinical observation was made of all

animals.

Prior to administration food was withheld from the test animals overnight.

Following the period of fasting the animals were weighed and the test item

was administered. Then the food was withheld for a further 3-4 hours.

 

Administration:

The test item was administered in a single dose by gavage using an

intubation cannula.

The test item was administered at a volume of 10 mL/kg body weight.

 

Dose Level:

The starting dose was selected to be 2000 mg/kg body weight. No compound

related mortality was recorded for any animal of step 1 or 2. Therefore,

according to the acute toxic class method regime no further testing was

required.

 

Observation:

The animals were observed for 14 days after dosing.

Weight Assessment:

The animals were weighed prior to the administration and once a week

thereafter.

 

Clinical Examination:

A careful clinical examination was made several times on the day of dosing.

Part of this were at least three observations within the first four hours postdose.

Animals were observed once a day thereafter.

Cageside observations included changes in the skin and fur, eyes and

mucous membranes. Also respiratory, circulatory, autonomic and central

nervous systems and somatomotor activity and behaviour pattern were

examined. Particular attention was directed to observations of tremor,

convulsions, salivation, diarrhoea, lethargy, sleep and coma.

 

Pathology:

At the end of the observation period the animals were sacrificed by an

overdosage of pentobarbital.

All animals were subjected to gross necropsy. All gross pathological changes

were recorded.

 

Evaluation of Results:

Individual reactions of each animal were recorded at each observation time.

Toxic response data were recorded by sex and dose level.

Nature, severity and duration of clinical observations were described.

Body weight changes were summarized in tabular form.

Necropsy findings were described.

 

Results:

The acute toxic class method was performed with the test item CAT-Acid

chloride.

A careful clinical examination was made several times on the day of dosing.

Part of this were at least three observations within the first four hours postdose.

Animals were observed once a day thereafter.

In the first step the test item was given at a dose of 2000 mg/kg body weight

to a group of 3 female rats (HsdRccHan:WIST) in a single exposure via

oral gavage.

Animal No. 1 of step 1 showed slightly reduced spontaneous activity and

apathy 45 minutes post dose. 105 minutes post dose slightly reduced

spontaneous activity, half eyelid-closure, apathy, as well as piloerection were

recorded. 3 hours 15 minutes, 4 hours 45 minutes, as well as 6 hours 45

minutes post dose moderately reduced spontaneous activity, complete

eyelid-closure, apathy and piloerection were recorded. 1 day post dose until

the end of the observation period no signs of toxicity were observed.

Animal No. 2 of step 1 showed slightly reduced spontaneous activity and

apathy 40, as well as 100 minutes post dose. 3 hours 40 minutes post dose

slightly reduced spontaneous activity, half eyelid-closure, apathy, as well as

piloerection were recorded. 1 day post dose until the end of the observation

period no signs of toxicity were observed.

Animal No. 3 of step 1 showed slightly reduced spontaneous activity and

apathy 40 minutes, 100 minutes, as well as 3 hours 40 minutes post dose.

1 day post dose until the end of the observation period no signs of toxicity

were observed.

No other treatment related effect was observed in any animal of step 1.

In the second step the test item was given at the same dose and in the same

manner to a further group of 3 female rats (HsdRccHan:WIST).

No treatment related effect was observed in any animal of step 2.

Following the acute toxic class regime of OECD 423 no further testing was

required.

Beside acute injection of blood vessels in the abdominal region, which is due

to the euthanasia injection, no special gross pathological changes were found

in any animal of any step.

Throughout the 14-days observation period no weight loss was recorded in

any animal. The weight gain was within the expected range.

Therefore, according to OECD Guideline 423, a sufficient estimation of the

acute oral toxicity of the test item is provided.

Conclusion:

Considering the reported data of this toxicity test it can be stated that the test

item CAT-Acid chloride showed slight oral toxic characteristics.

According to GHS (Globally Harmonized Classification System) the test

item CAT-Acid chloride was classified into Category 5 (LD50 cut-off:

unclassified).