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Administrative data

Description of key information

Acute toxicity of Aromatic hydrocarbons, C10-13, reaction products with branched nonene, sulphonated, sodium salts is low. Oral LD50 is in range 2000-5000, and dermal LD50 >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:
1959-12-02 till 1959-12-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited reporting. CoA not included in report. Studies performed in the 1950-1960 era did not have details of test material routinely stated in final reports.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Please see remarks below
Principles of method if other than guideline:
Limited reporting.
- 1 sex
- Acclimatisation period unknown.
- 3 to 4 hours fasting.
- Maximum volume of liquid was 33,33 ml/kg.
- Housing conditions are unknown.
- Observation period was 7 days.
- An assumption about a no tested dose level (31600 mg/kg) is made.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Trade name: Petro S (100% high nonene Naphthalene sulphonates)
Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: male albino rats, Sprague-Dawley strain
- Age at study initiation: no info
- Weight at study initiation: Weight range 97 to 120 grams
- Fasting period before study: 3 to 4 hours
- Housing: housed by groups in metal cages suspended above the droppings
- Diet (e.g. ad libitum): available at all times
- Water (e.g. ad libitum): available at all times
- Acclimation period: no info


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no info
- Humidity (%): no info
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): no info


IN-LIFE DATES: no info
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.1, 1.0, 10.0, 30.0 weight/volume solution of test material in distilled water

MAXIMUM DOSE VOLUME APPLIED: 33.33 ml/kg
Doses:
Dose levels:
31.6 mg/kg
100 mg/kg
316 mg/kg
1000 mg/kg
3160 mg/kg
10000 mg/kg
in 0.1, 1.0, 10.0, 30.0 w/v solution of test material in distilled water
No. of animals per sex per dose:
5 male rats per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: observations immediately after administration, 1, 4 and 24 hours on the day of administration, and daily thereafter. Weighing of survivors at termination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical and behavioral signs, body weight, histopathology
Statistics:
The moving average method was used to calculate the LD50 value (Horn, H.J., Biometrics 12, 311, 1956).
Sex:
male
Dose descriptor:
LD50
Effect level:
4 470 mg/kg bw
95% CL:
2 820 - 7 080
Mortality:
- Dose level 31.6, 100, 316, 1000 mg/kg: no animal died.
- Dose level 3160 mg/kg: 1 animal died within 24 hours.
- Dose level 10000 mg/kg: 5 animals died within 24 hours.
The assumption of total mortality at the 31600 mg/kg dosage level is made.
Clinical signs:
Dosage levels of:
- 31.6 mg/kg bw: normal appearance and behavior
- 100 mg/kg bw: normal appearance and behavior
- 316 mg/kg bw: normal appearance and behavior
- 1000 mg/kg bw: normal appearance and behavior
- 3160 mg/kg bw: immediately following administration normal appearance and behavior. At the 1-hour interval inactivity and labored respiration, ataxia and sprawling of the limbs. At the 4-hour interval ptosis and depressed righting and placement reflexes. At the 24-hour interval animals exhibited inactivity and with an additional day surviving animals appeared to have recovered.
- 10000 mg/kg bw: within 10 minutes the animals exhibited depression characterized by inactivity, labored respiration, ataxia, and sprawling of the limbs. Furthermore, ptosis and depressed righting and placement reflexes.
Body weight:
The average body weight of the surviving animals at each dosage level showed an increase over the respective initial average body weight, which was within normal range of values for rats of the sex, age, and strain used in this study.
Gross pathology:
Gross autopsies performed on the animals which died showed congestion of the lungs, kidneys, and adrenals, and irritation of the gastrointestinal tract. Gross autopsies perfomed at termination revealed no observable gross pathology.
Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The acute oral LD50 of the test item for male albino rats is 4470 mg/kg of body weight, with confidence limits from 2820 to 7080 mg/kg.
Executive summary:

There was limited reporting.

The study was performed with similarities to OECD Guideline 401 (Acute Oral Toxicity), but not according to GLP standards.

The test material was evaluated for its acute oral toxicity potential in albino rats when administered as gavage doses at levels of 31.6, 100, 316, 1000, 3160 and 10000 mg/kg to males. No mortality occured in animals dosed at the 31.6, 100, 316 and 1000 mg/kg level. At dose level 3160 mg/kg 1/5 animal died and all (5/5) animals died at the 10000 mg/kg level. Clinical signs of toxicity included depression, ptosis and depressed righting and placement reflexes. Gross pathologic examination on the animals that died showed congestion of the lungs, kidneys and adrenals, and irritation of the gastrointestinal tract. Gross pathologic examination at termination revealed nothing remarkable.

Conclusion: The acute oral LD50 of the test item for male albino rats is 4470 mg/kg of body weight, with confidence limits from 2820 to 7080 mg/kg.

According to GHS the substance is classified as toxicity category V.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
4 470 mg/kg bw
Quality of whole database:
The substance should be classified as GHS Cat.5 acute oral toxicity. No further testing required.
Database was adequate to complete assessment.

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:
March 1980 - April 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A limited reported study, 3 animals per sex, 3 animals with abraded skin, 24-h occlusive application. Substance in preparation
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Please see remarks below
Principles of method if other than guideline:
Principles other than guideline:
- limited reporting
- 6 albino rabbits (3 per sex)
- 3 animals with abraded skin
- 24-h occlusive application
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
PETRO BAF POWDER (65% Aromatic hydrocarbons, C10-13, alkylated, sulphonated, sodium salts, low nonene; C10-16 alkylbenzene sulphonic acid, sodium salt 35%)
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratories, Inc., denver, Pennsylvania
- Age at study initiation: no data
- Weight at study initiation: 2.37 - 2.75 kg
- Fasting period before study: no info
- Housing: individually housed in metal cages, which were elevated above the droppings
- Diet (e.g. ad libitum): Purina Rabbit Chow, ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: 10 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no info
- Humidity (%): no info
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): no info


IN-LIFE DATES: From: March 20, 1980 To: April 3, 1980
Type of coverage:
occlusive
Vehicle:
other: test substance moistened with 3 ml of distilled water
Details on dermal exposure:
TEST SITE
- Area of exposure: no info
- % coverage: clipping of approximately 30% of the total body surface of the skin on the back
- Type of wrap if used: Test substance applied under a sleeve of dental dam (gauze) which was wrapped around the trunk of the animal and secured with staples. The ends of the sleeve of dental dam were fastened with Johnson and Johnson Zonas porous tape to form an airtight occlusive wrap. Each rabbit was restrained in a Newmann harness and returned to its cage for a 24-hour exposure period.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): any unabsorbed test material was removed from the skin by washing with warm tap water
- Time after start of exposure: 24-h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): dosed at 2 g/kg
- Concentration (if solution): not applicable, test substance was moistened with 3 ml of distilled water per application
- Constant volume or concentration used: yes
- For solids, paste formed: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): test substance was moistened with 3 ml of distilled water per application
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
Duration of exposure:
24 hours
Doses:
2 g/kg moistened with 3 ml of distilled water per application
No. of animals per sex per dose:
6 rabbits: 3 males + 3 females (1 male and 2 female rabbits were abraded, the other animals only clipped)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations for systemic toxicity, mortality and skin irritation; weighing at study initiation and termination
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Statistics:
Not applicable.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality.
Clinical signs:
One rabbit was observed to show signs of toxicity: difficulty breathing, nasal discharge, nictitating membranes reddened and swollen with marked lacrimation on days 1 through 14.
Signs of skin irritation observed were slight to moderate erythema, edema and atonia on days 1 through 9, subsiding by day 10 in the majority of rabbits. Slight desquamation increasing to marked desquamation was noted beginning on days 4 or 5, continuing throughout the study. On days 4 through 7 slight to moderate fissuring was observed. On day 4 of the study all of the rabbits' test areas were leathery to touch and eschar formation was then noted on day 5 continuing throughout the study. Exfoliation began on day 6 or 7 in four of the rabbits and days 10 and 13 on two of the rabbits.
Body weight:
All animals gained weight over the 14-day observation period.
Gross pathology:
See clinical signs.
Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The single dose acute dermal LD50 of the test item , moistened with 3 ml of distilled water and applied to the skin for 24 hours, is greater than 2000 mg/kg bw. Because higher concentrations than 2000 mg/kg had not been tested and effects at those higher concentrations are unknown the test material was classified in Category 5 according to OECD-GHS.
Executive summary:

The test item was evaluated for its acute dermal toxicity potential in albino rabbits. The study is comparable to OECD Guideline 402 (Acute Dermal Toxicity). The study was designed and performed according to Good Laboratory Practice Standards.

For 24 hours 2 g/kg of the test substance is applied to the skin of six albino rabbits (test material moistened with 3 ml of distilled water per application). The test sites of three of the six animals were abraded. No mortalities occurred through the study. One rabbit was observed to show signs of toxicity involving difficulty breathing, nasal discharge, nictitating membranes reddened and swollen with marked lacrimation on days 1 through 14. Moderate to severe skin irritation was noted in all rabbits during the study.

Signs of skin irritation observed were slight to moderate erythema, edem and atonia on days 1 through 9, subsiding by day 10 in the majority of rabbits. Sligh desquamation increasing to marked desquamation was noted beginning on days 4 or 5, continuing throughout the study. On days 4 through 7 slight to moderate fissuring was observed. On day 4 of the study all of the rabbits test areas were leathery to touch and eschar formation was then noted on day 5 continuing throughout the study. Exfoliation began on day 6 or 7 in four of the rabbits and days 10 and 13 on two of the rabbits. Observations were up to 14 days.

The single dose acute dermal LD50 of the test item, moistened with 3 ml of distilled water and applied to the skin for 24 hours, is greater than 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
The overall weight of evidence leads to the well accepted conclusion for non-classification. Further in vivo testing is not justified.

Additional information

Acute oral toxicity:

Aromatic hydrocarbons, C10-13, reaction products with branched nonene, sulphonated, sodium salts are available with high and low nonene alkylation. These products are representative of what would be considered low and high toxicity ranges and therefore are key studies for the oral acute toxicity assessment.

 

Study

report#

Conc.
(%)

Dose (mg/kg)

Mortality

High nonene substitution

Kodoma (1959a)

100% high nonene substance

Tox id 3223

10

30

3160

10000

1/5 in 24h

5/5 in 24h         (LD50 = 4470)

Kodoma (1959b)

100% high nonene substance

Tox id 3225

10

30

3160

10000

1/5 in 24h

5/5 in 24h         (LD50 = 4470)

Gabriel (1980)

(86% high nonene substance + 14% Docusate)

80 -1948A

25

25

25

1000

2000

4000

0/5

3/5 in 24h

5/5 in 24h         (LD50 = 1866)

Low nonene substitution

Kodoma (1959c)

100% low nonene substance

Tox id 3212

10

30

3160

10000

0/5

5/5 in 24h         (LD50 = 5620)

Kuhn (1995)

(65% low nonene substance + 35% LAS)

2417-95

50

50

50

50

750

1500

2500

5050

0/10

5/10 in 48h

8/10 in 48h

10/10 in 24h     (LD50 = 1646)

Kodama (1959d)

100% low nonene substance

Tox id 3204

10

30

3160

10000

0/5

5/5 in 24h         (LD50 = 5620)

Anspach (1978)

(97% low nonene substance + 3% nonylphenol EO)

77-1025-21

50

50

50

2150

4640

10000

0/5

3/5 in 24h

5/5 in 1 h          (LD50 = 4300)

Kodama (1959e)

100% low nonene substance

Tox id 3226

10

30

3160

10000

0/5

5/5 in 24h         (LD50 = 5620)

Mastri (1970)

(65% low nonene substance + 35% LAS)

 IBT NO. A8728

50

50

4600

6800

0/4

4/4 in 48h         (LD50 = 5600)

 

For two of the high nonene substituted substances the results indicate that no classification is needed for CLP, but the high nonene product which contains 14% docusate, shows higher toxicity. The acute oral toxicity of docusate is 4620 mg/kg (IUCLID from ECB). On the other hand docusate is known to increase absorption and toxicity of other substances following oral intake.

For the low nonene substitution, the results from the low nonene product containing 35% LAS show the highest toxicity, and looks like an outlier compared to the other results. However, this could largely be explained with the presence of 35% LAS, which has on its own a LD50 between 1000 and 2000 mg/kg.

Overall, reports on the products with high and low nonene substituted show comparable, relatively low acute toxicity. For purpose of classification, these studies point at an LD50 in range 2000-5000 for the pure substance. No further studies seem necessary.

 

Acute dermal toxicity:

Results from the key study indicate low systemic toxicity following administration via dermal route. Application to the skin of 2 g/kg bw for 24 hours resulted to desquamation, fissuring, eschar formation and exfoliation. No mortality occurred. Only one animal showed signs of toxicity involving difficulty breathing, nasal discharge and nictitating membranes reddened and swollen with marked lacrimation.

(LD50 > 2000 mg/kg). Although this substance contains about 35% LAS, it can in view of the higher oral toxicity (see above) of such mixture considered to represent a worst case result already. Consequently, no further studies would be required. No classification for acute dermal toxicity is indicated.

 

Acute inhalation toxicity:

No data following testing via inhalation is available. REACH stipulates that testing by the inhalation route is appropriate if exposure of humans via inhalation is 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. No acute inhalation data is available on the substance; however it has a low vapour pressure of 0.0015 Pa at 20°C and the use of the substance is not expected to generate respirable aerosols. The substance shows (severe) irritating effects on skin (especially following repeated exposures) and classified for eye damage cat.1. In view of the low systemic toxicity following oral exposures, it can be expected that exposures via inhalation will be characterised by local effects. Testing for acute systemic toxicity via inhalation is therefore not indicated.


Justification for classification or non-classification

For purpose of classification, the available acute toxicity data following oral dosing all point at a LD50 in range 2000-5000. They also indicate that there is no difference between low or high nonene substitution. The substance therefore needs to be classified for acute toxicity according to GHS as Cat.5, but classification for CLP is not required.

Available data for acute dermal toxicity also show low systemic toxicity. The test indicates that local irritating effects are seen before any systemic effects occur. To this can be remarked that based on the physic-chemical properties of the substance, dermal absorption is likely to be lower than oral absorption. Further acute dermal testing is not justified with severely irritating materials, or even corrosive upon longer exposures. No classification is needed for acute dermal toxicity.

For acute inhalation toxicity the information for classification is lacking, and testing is not justified. REACH stipulates that testing by the inhalation route is appropriate if exposure of humans via inhalation is 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. No acute inhalation data is available on the substance; however it has a low vapour pressure of 0.0015 Pa at 20°C and the use of the substance is not expected to generate respirable aerosols. Based on the available data low systemic toxicity can also be expected via inhalation route.

Based on its physical appearance as solid there is no need for classification for aspiration hazard.