Bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc

Endpoint summary

Description of key information

LD50 Oral: 1800mg/kg bw  (OECD 401, GLP)
LD50 Dermal: >2000mg/kg bw  (OECD 402, GLP)

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline and GLP compliant study

Qualifier:

according to guideline

Guideline:

other: Directive 84/449/EEC, Method B1 OECD Guideline No. 401

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Species:

other: Rat, Sprague-Dawley

Vehicle:

other: 1% Carboxymethylcellulose in distilled water

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 800 mg/kg bw

95% CL:

1 400 - 2 200

Remarks on result:

other: Slope of mortallity curve: 4

Mortality:

Male: 500 mg/kg bw; Number of animals: 7; Number of deaths: 0
Male: 800 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 1000 mg/kg bw; Number of animals: 2; Number of deaths: 2
Male: 1260 mg/kg bw; Number of animals: 5; Number of deaths: 3
Male: 2000 mg/kg bw; Number of animals: 10; Number of deaths: 7
Male: 2500 mg/kg bw; Number of animals: 2; Number of deaths: 2
Male: 3200 mg/kg bw; Number of animals: 5; Number of deaths: 2
Male: 5000 mg/kg bw; Number of animals: 10; Number of deaths: 6
Male: 8000 mg/kg bw; Number of animals: 5; Number of deaths: 5

Female: 500 mg/kg bw; Number of animals: 7; Number of deaths: 0
Female: 800 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 1000 mg/kg bw; Number of animals: 2; Number of deaths: 1
Female: 1260 mg/kg bw; Number of animals: 5; Number of deaths: 2
Female: 2000 mg/kg bw; Number of animals: 10; Number of deaths: 5
Female: 2500 mg/kg bw; Number of animals: 2; Number of deaths: 1
Female: 3200 mg/kg bw; Number of animals: 5; Number of deaths: 5
Female: 5000 mg/kg bw; Number of animals: 10; Number of deaths: 7
Female: 8000 mg/kg bw; Number of animals: 5; Number of deaths: 5

Clinical signs:

Signs of toxicity related to dose levels:
Mortalities:

Mortalities occured amongst rats dosed at 1260mg/kg and above, within 1 and 47 hours after dosing

Clinical signs:
Signs of reaction to treatment shortly after dosing in all rats were pilo-erection and lethargy.
These were accompanies amongst rats from all groups by hunched posture, abnormal gait, decreased respiratory rate and pallor of the extremities.
Increased salivation was observed in all female rats dosed at 5000mg/kg and two female rats at 8000mg/kg.

A comatose like condition was observed amongst rats dosed at 2000 mg/kg and above.

Gasping was oberved in one female rat dosed at 5000 mg/kg and one female dosed at 8000 mg/kg.

Noisy respiration was observed in one female at 5000 mg/kg and two females at 8000 mg/kg.

Recovery, as judged by external appearance and behaviour, was apparently complete by day 5.

Gross pathology:

Effects on organs:
Autopsy of animals that had died during the study revealed pallor of the kidneys and spleen. Occasional incidences of haemorrhagic lungs, pallor and patchy livers and pale lungs were also observed.

Terminal autopsy findings were normal.

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 800 mg/kg bw

Quality of whole database:

Information from migrated NONS file, as per inquiry number 06-0000021669-59-0000.

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline and GLP compliant study

Qualifier:

according to guideline

Guideline:

other: Based on OECD Guideline for the Testing of Chemiclas No. 402

GLP compliance:

yes

Limit test:

yes

Species:

other: rat, Sprague-Dawley

Type of coverage:

occlusive

Vehicle:

other: 1% methylcellulose

Duration of exposure:

24 h

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

Signs of toxicity related to dose levels:
No signs of systemic toxicity were noted during the study period. No toxicologically significant effects on bodyweight were noted during the study.

Gross pathology:

Effects on organs:
No abnormalities were noted at necropsy of animals killed at the end of the study.

Other findings:

Signs of toxicity (local):
No signs fo dermal irritation were noted during the study period.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Information from migrated NONS file, as per inquiry number 06-0000021669-59-0000.

Additional information

Acute Toxicity:Oral 

In acute oral toxicity study carried out in male and female Sprague Dawley

rats, (no guideline, GLP) the LD50 was determined to be > =1200 mg/kg bw. In two further acute oral toxicity studies carried out according to a standard acute method (OECD 401 guideline tests, maximum dose 8000mg/kg bw) the LD50 was determined to be 1800 mg/kg bw with a 95% CL of 1400 - 2200 mg/kg bw. Mortalities were evident on both sexes from 1000 mg/kg bw and clinical observations in all animals indicated systemic toxicity. The key study was chosen as the study with the most reliable and adequate results and was the study with no technical errors. The key value was LC50 =1800 mg/kg bw as the lower dose descriptor (>=1200 mg/kg bw) was derived from a study when no adherence to a guideline was reported.

 

Acute Toxicty: Dermal

In an acute dermal toxicity studies carried out in 5 male and 5 female animals (OECD 402/GLP, semi-occlusive application, 2000mg/kg bw), no deaths occurred and no signs of local toxicity were observed. The LD50 value was

>2000mg/kg bw.

In two acute dermal toxicity studies carried out in 5 male and 5 female animals (guideline limit tests, occlusive application, 2000mg/kg bw), no deaths occurred and no signs of local toxicity were observed. Both tests were carried out in accordance with OECD 402/GLP. The key study was chosen as the study that provided more supporting information. The LD50 value >2000mg/kg bw from the key study was chosen as the key value for the acute dermal toxicity endpoint.

Justification for selection of acute toxicity – oral endpoint
OECD Guideline and GLP compliant study. The study with the lowest dose descriptor is of lower quality (not a guideline study).

Justification for selection of acute toxicity – dermal endpoint
OECD Guideline and GLP compliant study

Justification for classification or non-classification

According to the Directive 67/548/EEC, the substance bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc (CAS No. 42405-40-3) is classified as acutely toxic. 

Xn, Harmful: R22 Harmful if swallowed

According to the CLP Regulation, the substance bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc (CAS No. 42405-40-3)  is classified as:  Acute tox 4. Warning, H302: Harmful if swallowed.