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Diss Factsheets

Administrative data

Description of key information

Key study: OECD Guideline 423 (Acute Oral Toxicity).  GLP study. The acute toxicity of test substance was determined to be LD50: greater than 2000 mg/kg bw.
Key study: OECD Guideline 402 (Acute Dermal Toxicity). GLP study. The acute toxicity of test substance was determined to be LD50: 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 14, 2011 to January 3, 2012
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:
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 8147
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: approx. 10-11 weeks old.
- Weight at study initiation: Given in the table
- Fasting period before study: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance.
- 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 cageenrichment (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): ad libitum
- Acclimation period: Acclimatization period was at least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 +/- 3.0ºC (actual range: 19.9 - 21.7ºC)
- Humidity (%): 40-70% (actual range: 42 - 62%)
- Air changes (per hr): 15 approx.
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light and 12 hours darkness per day.

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.081 mL/kg body weight

Doses:
2000 mg/kg (2.081 mL/kg) body weight
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: observations once daily and weighing on 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 to very severe. Maximum grade 3: grading slight to severe. Maximum grade 1: presence is scored.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured.
Clinical signs:
other: Hunched posture and/or uncoordinated movements were noted in all animals on Day 1. One animal showed hunched posture on Day 2 also.
Other findings:
- Other observations:
Macroscopic findings: Two animals showed reddish discoloration of the thymus. No other 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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Males

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MALES

2000 mg/kg

 

ANIMAL 1

 

Posture

 Hunched posture

(1)

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Gait / motility

Uncoordinated movements

(3)

1

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

ANIMAL 2

 

Posture

 Hunched posture

(1)

1

1

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

Gait / motility

Uncoordinated movements

(3)

1

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

ANIMAL 3

 

Posture

 Hunched posture

(1)

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Gait / motility

Uncoordinated movements

(3)

1

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

 

FEMALES

2000 mg/kg

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANIMAL 4

 

Posture

 Hunched posture

(1)

1

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

-

ANIMAL 5

 

Posture

 Hunched posture

(1)

1

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Skin/fur

Piloerection

(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

MALES

2000 mg/kg

1

189

209

210

 

2

174

197

210

 

3

180

199

217

 

 

 

MEAN

181

199

212

 

ST. DEV.

8

3

4

 

N

3

3

3

 

FEMALES

2000 mg/kg

4

197

226

229

 

5

170

192

189

 

6

197

244

241

 

 

 

MEAN

188

221

220

 

ST.DEV.

16

26

27

 

N

3

3

3

Table 4. Macroscopic findings.

ANIMAL

ORGAN

FINDING

DAY OF DEATH

MALES 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

 Thymus

Discolouration, reddish

Scheduled necropsy

Day 15 after treatment

5

 

No findings noted

Scheduled necropsy

Day 15 after treatment

6

 Thymus

 Discolouration, reddish

Scheduled necropsy

Day 15 after treatment

 

 

 

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 value of Reaction products of n-octanol and acrylic acid, first distillation pitch in Wistar rats was determinated to be greater than 2000 mg/kg b.w.
Executive summary:

The acute oral toxicity of the substance was determinated according to the OECD 423 test guideline with GLP. The oral LD50 value of Reaction products of n-octanol and acrylic acid, first distillation pitch in Wistar rats was established to exceed 2000 mg/kg body weight. Based on these results, the test substance 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 January 12, 2012 to January 26, 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
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: approx. 10 weeks old.
- Weight at study initiation: Given in the table
- 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 cageenrichment (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): ad libitum
- Acclimation period: Acclimatization period was 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 (actual range: 19.8 - 22.1ºC)
- Humidity (%): 40-70% (actual range: 39 - 66%)
- Air changes (per hr): 15 approx.
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light and 12 hours darkness per day.
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: approx. 25 cm² for males and 18 cm² for females.
- % coverage: 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): the 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 (2.081 mL/kg) bw.
- Constant volume or concentration used: yes

Duration of exposure:
24 h
Doses:
2000 mg/kg (2.081 mL/kg) bw.
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Observation once daily; weighing days 1 (pre-administration), 8 and 15.
- Other examinations performed:
clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. 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 occured.
Clinical signs:
other: Chromodacryorrhea and/or piloerection were noted among the animals on Days 1 and/or 2.
Other findings:
One male showed dark red discolouration of the lungs at macroscopic post mortem examination. No further 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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Males 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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MALES

2000 mg/kg

(1)

 

ANIMAL 1

Skin/fur

piloerection

-

-

1

-

-

-

-

-

-

-

-

-

-

-

-

-

-

ANIMAL 2

No clinical signs noted

 

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

ANIMAL 3

Skin/fur

Scales (treated skin)

(3)

-

-

-

-

-

-

-

1

-

-

-

-

-

-

-

-

-

ANIMAL 4

Secretion/excretion

Chromodacryorrhoea (Snout)

(3)

-

1

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

ANIMAL 5

Secretion/excretion

Chromodacryorrhoea (Snout)

(3)

-

-

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

 

FEMALES

2000 mg/kg

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANIMAL 6

No clinical signs noted

 

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

ANIMAL 7

Skin/fur

Scales (treated skin)

(3)

-

-

-

-

-

-

1

1

1

-

1

1

-

-

-

-

-

ANIMAL 8

Skin/fur

Piloerection

(1)

-

-

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

Secretion/excretion

Chromodacryorrhoea (Snout)

(3)

-

-

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

ANIMAL 9

Skin/fur

Piloerection

(1)

-

-

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

Secretion/excretion

Chromodacryorrhoea (Snout)

(3)

-

1

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

ANIMAL 10

Skin/fur

Piloerection

(1)

(3)

-

-

-

-

1

-

1

-

-

-

-

1

-

1

-

1

-

1

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Secretion/excretion

Chromodacryorrhoea (Snout)

(3)

-

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Table 3. Body weigh (grams)

SEX/DOSE LEVEL

ANIMAL

DAY 1

DAY 8

DAY 15

MALES 2000 mg/kg

1

288

290

325

 

2

270

273

300

 

3

282

290

314

 

4

283

292

324

 

5

271

282

305

 

MEAN

279

285

314

 

ST. DEV.

8

8

11

 

N

5

5

5

 

FEMALES 2000 mg/kg

6

196

194

210

 

7

211

209

221

 

8

194

188

204

 

9

188

185

201

 

10

198

196

214

 

MEAN

197

194

210

 

ST.DEV.

8

9

8

 

N

5

5

5

Table 4. Macroscopic findings

ANIMAL

ORGAN

FINDING

DAY OF DEATH

MALES 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

Lungs

Discolouration, dark red

Scheduled necropsy

Day 15 after treatment

5

 

 

Scheduled necropsy

Day 15 after treatment

FEMALES 2000 mg/kg

6

 

No findings noted

Scheduled necropsy

Day 15 after treatment

7

 

No findings noted

Scheduled necropsy

Day 15 after treatment

8

 

No findings noted

Scheduled necropsy

Day 15 after treatment

9

 

No findings noted

Scheduled necropsy

Day 15 after treatment

10

 

No findings noted

Scheduled necropsy

Day 15 after treatment

Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 value of Reaction products of n-octanol and acrylic acid, first distillation pitch in Wistar rats was determinated to be greater than 2000 mg/kg bw.
Executive summary:

The acute dermal toxicity of the substance was determinated according to the OECD 402 test guideline with GLP. The dermal LD50 value of Reaction products of n-octanol and acrylic acid, first distillation pitch in Wistar rats was established to exceed 2000 mg/kg body weight.

Based on these results, the test substance 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

Acute oral toxicity:

Key study: The acute oral toxicity of the substance was determinated according to the OECD 423 test guideline with GLP. The oral LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight.

Acute dermal toxicity:

Key study: The acute dermal toxicity of the substance was determinated according to the OECD 402 test guideline with GLP. The dermal LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight.


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: non classified.

Dermal LD50 >2000 mg/kg bw: non classified.