Decanoic acid, mixed esters with dipentaerythritol, heptanoic acid and octanoic acid.

Endpoint summary

Description of key information

Acute Toxicity: Oral

The oral LD50 value of Hatcol 5127  in Wistar rats was established to exceed 2000 mg/kg body weight.

According to the OECD 423 test guideline the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Based on these results Hatcol 5127 does not have to be classified and has on obligatory labelling requirement for oral toxicity according to the OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998) and EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC).

Acute Toxicity: Dermal

The substance, CAS: 70851-04-6; EC: 453-480-2, is analogous to the substances to be read across to, in terms of basic form, and the degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of acute dermal toxicity. Based on the available information to read across to, the substance  is not expected to be acutely toxic via the dermal route.

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:

30 March 2004 to 15 April 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Remarks:

Crl:(WI) BR (outbred, SPF-Quality).

Sex:

female

Details on test animals or test system and environmental conditions:

Test species:
Species: Rat, Wistar strain Crl:(WI) BR (outbred, SPF-Quality). Recognised by international guidelines as the recommended test system (e.g. OECD, EC).
Source: Charles River Deutschland, Sulzfeld, Germany.
Number of animals: 6 Females (nulliparous and non-pregnant). Each dose group consisted of 3 animals.
Age and body weight: Young adult animals (approx. 8 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.
Identification: Earmark.

Animal husbandry:
Conditions
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 +/- 3.0°C (actual range: 17.5 -24.2°C), a relative humidity of 30-70% (actual range: 29 - 67%) and 12 hours artificial fluorescent light and 12 hours darkness per day.

Accommodation
Group housing of 3 animals per sex per cage in labelled Macroton cages (type IV; height 18 cm.) containing purified sawdust as bedding material {Woody Clean bedding (Woody-Clean type 3/4; Tecnilab-BMI BV, Someren, The Netherlands).
Certificates of analysis were examined and then retained in the NOTOX archives. Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.

Diet
Free access to standard pelleted laboratory animal diet (from Altromin (code VRF 1), Lage, Germany). Certificates of analysis were examined and then retained in the NOTOX archives.

Water
Free access to tap-water. Certificates of quarterly ana1ysis were examined and then retained in the NOTOX archives.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Method
Oral gavage, using a stainless steel stomach tube.

Fasting
Food was withheld overnight (for a maximum of 20 hours) prior to dosing until 3-4 hours after administration of the test substance.

Frequency
Single dosage, on day 1.

Dose level (volume)
2000 mg/kg (2.04 ml/kg) body weight.

Dose volume calculated as dose level: specific gravity.

Doses:

Single dose of 2000 mg/kg bw adminstered to animals on day 1

No. of animals per sex per dose:

3 animals per dose group (nulliparous and non-pregnant)

Control animals:

not specified

Details on study design:

Observations
Mortality/Viability: Twice daily.
Body weights: Day 1 (pre-administration), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing (day1) and once daily thereafter, until day 15. The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1).

Necropsy: at the end of the observation period, all animals were sacrificed by asphyxiation using an oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.

Statistics:

Not applicable to this method.

Preliminary study:

Not applicable

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

Hunched posture was noted among the animals of the second group on day 1.

Body weight:

The mean body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Clinical signs

Test day	Max grade	1	1	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15
Hours after treatment		0	2	4
Females 2000 mg/kg		-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Animal 1 No clinical signs noted		-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Animal 2 No clinical signs noted		-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Animal 3 No clinical signs noted		-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Females 2000 mg/kg
Animal 4 Hunched posture	(1)	1	1	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Animal 5 Hunched posture	(1)	1	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Animal 6 Hunched posture	(1)	1	1	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-

 

 

Body weights (gram)

Sex/Dose level	Animal	Day 1	Day 8	Day 15
Females 2000 mg/kg
	1	182	237	267
	2	164	212	238
	3	164	212	232
	Mean	170	220	246
	ST Dev.	10	14	19
	N	3	3	3
Females 2000 mg/kg
	4	180	217	229
	5	196	234	257
	6	183	215	234
	Mean	186	222	240
	ST Dev.	9	10	15
	N	3	3	3

                               

Macroscopic findings

Animal organ	Finding	Day of death
Females 2000 mg/kg
1	No findings noted	Scheduled necropsy Day 15 after treatment
2	No findings noted	Scheduled necropsy Day 15 after treatment
3	No findings noted	Scheduled necropsy Day 15 after treatment
4	No findings noted	Scheduled necropsy Day 15 after treatment
5	No findings noted	Scheduled necropsy Day 15 after treatment
6	No findings noted	Scheduled necropsy Day 15 after treatment

 

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 value of Hatcol 5127 in Wistar rats was established to exceed 2000 mg/kg body weight.
According to the OECD 423 test guideline the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.
Based om these results Hatcol 5127 does not have to be classified and has no obligatory requirement for oral toxicity according to the OECD Harmonized integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998) and EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC).

Executive summary:

Assessment of acute oral toxicity with Hatcol 5127 in the rat (Acute Toxic Class Method).

The study was carried out based on the guidelines described in: "Acute Toxicity-Oral, Acute Toxic Class Method", OECD No.423 (2001); “Acute Oral Toxicity”; EC Commission Directive 96/54/EC, Part 8.1 tris (1996); Environmental Protection Agency (EPA): Health Effects Test Guidelines OPPTS 870.1100 (2002), "Acute Oral Toxicity- Acute Toxic Class Method" and JMAFF Japanese test guidelines (2000).

 

Hatcol 5127 was administered by oral gavage to two subsequent groups of three female rat Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).

 

No mortality occurred.

 

Hunched pasture was noted among the animals of the second group on day 1.

 

The mean body weight gain shown by the animals aver the study period was considered to be normal.

 

No abnormalities were found at macroscopic post mortem examination of the animals.

 

The oral LD50 value of Hatcol 5127 in Wistar rats was established to exceed 2000 mg/kg body weight.

 

According to the OECD 423 test guideline the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

 

Based on these results Hatcol 5127 does not have to be classified and has no obligatory labelling requirement for oral toxicity according to the OECD Harmonized lntegrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998) and EC criteria for classification and labelling requirements for dangerous substances and preparations {Council Directive 67/54BIEEC).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

K1

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: dermal

Type of information:

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

Remarks:

1 substance available for read across

Adequacy of study:

weight of evidence

Justification for type of information:

see the attached justification in section 13 for full details

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: CAS 71010-76-9

Interpretation of results:

GHS criteria not met

Conclusions:

The substance, CAS: 70851-04-6; EC: 453-480-2, is analogous to the substances to be read across to, in terms of basic form, and the degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of acute dermal toxicity. Based on the available information to read across to, the substance is not expected to be acutely toxic via the dermal route.

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study with acceptable restrictions. (Lack of data on test material.)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted in 1987

Deviations:

yes

Remarks:

(no data on test substance purity)

Qualifier:

equivalent or similar to guideline

Guideline:

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

Version / remarks:

adopted in1992

Deviations:

yes

Remarks:

(no data on test substance purity)

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

adopted in 1998

Deviations:

yes

Remarks:

(no data on test substance purity)

GLP compliance:

yes

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: Harlan
- Age at study initiation: 9 - 10 weeks
- Weight at study initiation: 247 - 253 g (males), 217 - 239 g (females)
- Housing: animals were group housed by sex upon receipt and individually housed upon assignment to study in compliance with the National Research Council " Guide for the Care and Use of Laboratory Animals".
- Diet: Harlan Teklad Rodent Diet, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 23 - 59
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 9 Jan 2006
To: 23 Jan 2006

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped skin of the dorsal area of the trunk
- Type of wrap if used: the treated skin site was covered with a gauze patch/dental dam, wrapped with an elastic bandage and secured with non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was removed with water
- Time after start of exposure: 24 h

Duration of exposure:

24 h

Doses:

2000 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 and weighing: Clinical observations were recorded immediately after dosing and at approximately 1, 2.5 and 4 h after dosing and daily thereafter through Day 15. Animals were weighed prior to dosing on Day 1 and on Days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality/morbidity (twice daily)

Statistics:

Body weights were summarized using descriptive statistics (mean and standard deviation).

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Body weight:

Body weight gains of all animals were withinthe normal ranges during the whole study period.

Gross pathology:

Necropsy revealed no substance-related findings.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
EU: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

K1

Additional information

Assessment of acute oral toxicity with Hatcol 5127 in the rat (Acute Toxic Class Method).

The study was carried out based on the guidelines described in: "Acute Toxicity-Oral, Acute Toxic Class Method", OECD No.423 (2001); “Acute Oral Toxicity”; EC Commission Directive 96/54/EC, Part 8.1 tris (1996); Environmental Protection Agency (EPA): Health Effects Test Guidelines OPPTS 870.1100 (2002), "Acute Oral Toxicity- Acute Toxic Class Method" and JMAFF Japanese test guidelines (2000).

 

Hatcol 5127 was administered by oral gavage to two subsequent groups of three female rat Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).

 

No mortality occurred.

 

Hunched pasture was noted among the animals of the second group on day 1.

 

The mean body weight gain shown by the animals aver the study period was considered to be normal.

 

No abnormalities were found at macroscopic post mortem examination of the animals.

 

The oral LD50 value of Hatcol 5127 in Wistar rats was established to exceed 2000 mg/kg body weight.

 

According to the OECD 423 test guideline the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

 

Based on these results Hatcol 5127 does not have to be classified and has no obligatory labelling requirement for oral toxicity according to the OECD Harmonized lntegrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998) and EC criteria for classification and labelling requirements for dangerous substances and preparations {Council Directive 67/54BIEEC).

Acute Dermal Toxicity

CAS 71010-76-9

An acute dermal toxicity study (limit test) was performed on Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) comparable to OECD Guideline 402 and GLP (Mallory, 2006). 5 male and female Sprague-Dawley rats were exposed to 2000 mg test substance /kg bodyweight for 24 hours on the back skin under semiocclusive conditions. The observation period was 14 days. No clinical signs of systemic toxicity were noted in any animal during the study period. Body weight gain and necropsy at study termination revealed no abnormalities. Thus, the acute dermal LD50 in rats for Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid was found to exceed 2000 mg/kg bw.

Justification for classification or non-classification

Based on the available information, the substance does not meet the classification criteria for acute toxicity according to Regulation (EC) 1272/2008.