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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

LD50 oral:>5000 mg/kg bw (OECD 401)


LD50 dermal:>2000 mg/kg bw (OECD 402)


LD50 inhalation:>5 mg/L (OECD 403)


 


 

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:
2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
water
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality observed
Clinical signs:
other: no clinical sign observed
Body weight:
other body weight observations
Remarks:
Body weight increased
Gross pathology:
No pathological changes were observed at necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
Oral LD50 was greater than 5000 mg/kg bw for both mele and female Wistar rats.
Executive summary:

In the acute oral toxicity study according to OECD TG 401, 10/sex/group of rats were administrated with test item (5000 mg/kg/bw) by oral gavage. No toxic signs were observed after application of test item, and no death occurred within two weeks.No pathological changes were observed at necropsy.Oral LD50 was greater than 5000 mg/kg bw for both male and female Wistar rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
not specified
Test type:
fixed concentration procedure
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Center of Experimental Animals,AMMS,Beijing
- Weight at study initiation: 180-220 g
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-26°C
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
water
Mass median aerodynamic diameter (MMAD):
< 1 µm
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Temperature:20-24℃
- Humidity:100%
- Air flow rate: 0.8 m3/hr


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: smaller than 1μm
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
5 h
Concentrations:
5 mg/L
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5 mg/L air
Based on:
test mat.
Exp. duration:
5 h
Mortality:
No animal died during the study.
Clinical signs:
other: No clinical signs observed during the study.
Body weight:
Body weight increased
Gross pathology:
No pathological changes were observed at necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
The inhalation LC50 of test item was greater than 5 mg/L for both male and female Wistar rats.
Executive summary:

In an acute inhalation toxicity study according to OECD TG 403,  10 male and 10 female Wistar rats were exposed to test item at the dose level of 5 mg/L for 5 hours and afterwards observed for 14 days after removal of the test item.No clinical toxic signs were observed after application of test item and no death occurred with two weeks.No pathological changes were observed at necropsy.Inhalation LD50 was determined as larger than 5 mg/L for both male and female Wistar rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
> 5 mg/L air
Physical form:
inhalation: aerosol

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:
2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
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
- Rationale for alternative/additional species to rat (if applicable)
- Source: Center of Experimental Animals, AMMS,Beijing
- Weight at study initiation: 180-220 g
- Acclimation period:5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26°C
- Humidity (%): 40-60%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 4 cm* 5 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed away by soap and clean water
- Time after start of exposure:24 hours


Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Clinical signs observation conducted
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death occured.
Clinical signs:
other: No toxic signs were observed.
Body weight:
other body weight observations
Remarks:
Body weight increased
Gross pathology:
No pathological changes were observed at necropsy.
Other findings:
- Organ weights:
- Histopathology:
- Potential target organs:
- Other observations:
Interpretation of results:
GHS criteria not met
Conclusions:
Acute dermal LD50 was larger than 2000 mg/kg bw for both male and female Wistar rats.
Executive summary:

In an acute dermal toxicity study according to OECD TG 402,  10 male and 10 female Wistar rats were exposed to test item at the dose level of 2000 mg/kg bw for 24 hours and afterwards observed for 14 days after removal of the test item.No clinical toxic signs were observed after application of test item and no death occurred with two weeks.No pathological changes were observed at necropsy.Dermal LD 50 was determined as larger than 2000 mg/kg bw for both male and female Wistar rats.


 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD100
Value:
> 2 000 mg/kg bw

Additional information

Acute Oral Toxicity


In the acute oral toxicity study according to OECD TG 401, 10/sex/group of rats were administrated with test item (5000 mg/kg/bw) by oral gavage. No toxic signs  were observed after application of test item, and no death occurred within two weeks.No pathological changes were observed at necropsy.Oral LD50 was greater than 5000 mg/kg bw for both mle and female Wistar rats.


 


Acute Inhalation Toxicity


In an acute inhalation toxicity study according to OECD TG 403,  10 male and 10 female Wistar rats were exposed to test item at the dose level of 5 mg/L for 5 hours and afterwards observed for 14 days after removal of the test item.No clinical toxic signs were observed after application of test item and no death occurred with two weeks.No pathological changes were observed at necropsy.Inhalation LD50 was determined as larger than 5 mg/L for both male and female Wistar rats.


 


Acute Dermal Toxicity


In an acute dermal toxicity study according to OECD TG 402,  10 male and 10 female Wistar rats were exposed to test item at the dose level of 2000 mg/kg bw for 24 hours and afterwards observed for 14 days after removal of the test item.No clinial toxic signs were observed after application of test item and no death occurred with two weeks.No pathological changes were observed at necropsy.Dermal LD 50 was determined as larger than 2000 mg/kg bw for both male and female Wistar rats.

Justification for classification or non-classification

Based on the available information in the dossier, the substance Reaction product of 2-hydroxybenzoic acid, styrene and oxozinc does not need to be classified for acute toxicity or specific target organ toxicity — single exposure when the criteria outlined in CLP Regulation (Annex I of 1272/2008/EC) are applied.