[No public or meaningful name is available]

Endpoint summary

Description of key information

Key study: Acute oral toxicity. OECD Guideline 423. GLP study. The acute oral toxicity of the test substance was determined to be greater than 2000 mg/kg bw.
Key study: Acute dermal toxicity. OECD Guideline 402. GLP study. The acute dermal toxicity of the test substance was determined to be greater than 2000 mg/kg bw.

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:

From December 12, 2011 to July 26, 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed according to the OECD 423 Guideline, with GLP.

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: JMAFF guidelines 2000 (Japanese Ministry of Agriculture, Forestry and Fisheries)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Young adult animals (approx. 10 weeks old)
- Weight at study initiation: From 170 to 203 g bw. Body weight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.
- Housing: Group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
- Diet (e.g. ad libitum): Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0ºC
- Humidity (%): 40-70%
- Air changes (per hr): approximately 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day.

IN-LIFE DATES: From December 14, 2011 to January 3, 2012

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL.
- Amount of vehicle (if gavage): 8.39 g/kg.
- Justification for choice of vehicle: The vehicle was selected based on trial formulations and on test substance data supplied by the sponsor.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw.

DOSAGE PREPARATION: The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of the vehicle and density of the test substance.

Doses:

2000 mg/kg (10mL/kg) bw.

No. of animals per sex per dose:

6 females separated in two groups of three.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days.
- Frequency of observations and weighing:
Mortality/viability: Twice daily.
Body weights: Days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical signs: At periodic intervals on the day of dosing (Day 1) 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).

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Hunched posture and/or piloerection were noted in all animals on Day 1. One animal showed hunched posture on Day 2.

Gross pathology:

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

Table 1. MORTALITY DATA

TEST DAY	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	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
FEMALES 2000 mg/kg	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-

 

 

Table 2. CLINICAL SIGNS

 

TEST DAY		1	1	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15
HOURS AFTER TREATMENT	Max Grade	0	2	4
FEMALES 2000 mg/kg
ANIMAL 1
Posture  Hunched posture	(1)	-	1	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Skin / fur Piloerection	(1)	-	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
ANIMAL 2
Posture  Hunched posture	(1)	-	1	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Skin / fur Piloerection	(1)	-	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
ANIMAL 3
Posture  Hunched posture	(1)	-	1	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Skin / fur Piloerection	(1)	-	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
FEMALES 2000 mg/kg
ANIMAL 4
Posture  Hunched posture	(1)	-	1	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-
ANIMAL 5
Posture  Hunched posture	(1)	-	1	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-
ANIMAL 6
Posture  Hunched posture	(1)	-	1	1	1	-	-	-	-	-	-	-	-	-	-	-	-	-

-      = SIGN NOT OBSERVED / . = OBSERVATION NOT PERFORMED / + = ANIMAL DEAD

 

 

Table 3. BODY WEIGHTS (GRAM)

 

SEX/DOSE LEVEL	ANIMAL	DAY 1	DAY 8	DAY 15
FEMALES 2000 MG/KG	1	173	192	198
	2	188	206	220
	3	170	188	199
	MEAN	177	195	206
	ST. DEV.	10	9	12
	N	3	3	3
FEMALES 2000 MG/KG	4	193	226	228
	5	189	212	217
	6	203	227	237
	MEAN	195	222	227
	ST. DEV.	7	8	10
	N	3	3	3

 

 

Table 4. 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
FEMALES 2000 mg/kg
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:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 value of the test substance in Wistar rats was determined to be greater than 2000 mg/kg bw.

Executive summary:

Assessment of acute oral toxicity with Condensation products of cyclopentanone and pentaldehyde, fractionation pitch in the rat (Acute Toxic Class Method) was determinated according to the OECD 423 Guideline, with GLP.

The oral LD₅₀ value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight.

Based on these results, Condensation products of cyclopentanone and pentaldehyde, fractionation pitch does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the:

- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011)

- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Klimisch 1 and the study was carried out in accordance with internationally valid GLP principles.

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:

From December 12, 2011 to July 26, 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed according to the OECD 402 Guideline, with GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: JMAFF Guidelines 2000 (Japanese Ministry of Agriculture, Forestry and Fisheries)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Young adult animals (approx. 10 weeks old)
- Weight at study initiation: From 279 g to 294 g (males) and from 187 g to 202 g (females). Body weight variation did not exceed +/- 20% of the sex mean.
- Housing: Individually housed in labeled Makrolon cages (MIII type, height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
- Diet (e.g. ad libitum): Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions. During the acclimatization period the animals were group housed in Makrolon cages (MIV type, height 18 cm).

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0ºC.
- Humidity (%): 40-70%.
- Air changes (per hr): approximately 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day.

IN-LIFE DATES: From January 12, 2012 to January 26, 2012.

Type of coverage:

semiocclusive

Vehicle:

propylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: approx. 25 cm2 in males; approx. 18 cm2 in females.
- % coverage: approx. 10% of the total body surface.
- Type of wrap if used: dressing consisting of a surgical gauze patch (Surgy 1D)*, successively covered with aluminum foil and Coban elastic bandage*. A piece of Micropore tape* was additionally used for fixation of the bandages in females only.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was cleaned of residual test substance using tap water.
- Time after start of exposure: 24 h.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg (10 mL/kg) bw.
- Concentration (if solution): Concentration in vehicle was 200 mg/mL.
- Constant volume or concentration used: yes.

VEHICLE
- Amount(s) applied (volume or weight with unit): 8.39 g/kg.

Duration of exposure:

24h

Doses:

2000 mg/kg (10 mL/kg) bw.

No. of animals per sex per dose:

5 animals.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days.
- Frequency of observations and weighing:
Mortality/Viability: Twice daily.
Body weights Days: 1 (pre-administration), 8 and 15.
Clinical signs: at periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: yes.
- Other examinations performed:
Clinical signs:
The time of onset, degree and duration were recorded and the symptoms graded according to fixed scales:
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)

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Hunched posture, chromodacryorrhoea, piloerection and/or ptosis were noted in all animals on Days 1 and/or 2. Brown staining and/or scales were seen in the treated skin-area among the animals between Days 1 and Day 11. Scales and/or scabs were noted on th

Gross pathology:

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

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 value of the test substance in Wistar rats was determinated to be greaeter than 2000 mg/kg body weight.

Executive summary:

Assessment of acute dermal toxicity with Condensation products of cyclopentanone and pentaldehyde, fractionation pitch in the rat was determinated according to the OECD 402 Guideline, with GLP.

The dermal LD₅₀ value of the test substance in Wistar rats was determinated to be greaeter than 2000 mg/kg body weight.

Based on these results, Condensation products of cyclopentanone and pentaldehyde, fractionation pitch does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the:

- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011)

- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Klimisch 1 and the study was carried out in accordance with internationally valid GLP principles.

Additional information

Key study: Experimental result on test item Condensation products of cyclopentanone and pentaldehyde, fractionation pitch.

Acute oral toxicity:

The acute oral toxicity of the test substance was determined according to the OECD 423 Guideline, with GLP. The oral LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg bw.

Acute dermal toxicity:

The acute dermal toxicity of the test substance was determined according to the OECD 402 Guideline, with GLP. The dermal LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg bw.

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

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

Justification for classification or non-classification

Oral LD50 > 2000 mg/kg bw: not classified.

Dermal LD50>2000 mg/kg bw: not classified.