Registration Dossier

Administrative data

Description of key information

The test item was highly corrosive to rabbit skin and eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD guideline or GLP defined, acceptable restrictions (incomplete documentation).
Reason / purpose:
reference to same study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
, long exposure duration of 20 hours, no 48 and 72-hour reading
Principles of method if other than guideline:
other: undiluted test substance on the back for 1, 5, 15 min. and 20 h, undiluted testsubstance to the ear for 20 hours, observation time: 8 d (no further information)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.91 and 3.17 kg
Type of coverage:
semiocclusive
Preparation of test site:
other: back and inner surface of ear
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
back = 1, 5, 15 min and 20 h
ear =20 h
Observation period:
8 d
Number of animals:
2
Details on study design:
TEST SITE (BACK)
- Area of exposure: 2.5 cm x 2.5 cm
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(back)
Time point:
other: 24h and 8 d
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Duration of treatment: 1, 5, 15 min. and 20 h
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(back)
Time point:
other: 24 h and 8 d
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Duration of treatment: 1, 5, 15 min. and 20 h
Irritant / corrosive response data:
Back: Both treated animals showed weak (1min; 5 min) to severe (20 h) necrosis, with an increasing area of necrosis during the observation period.
Ear: Both treated animals showed severe necrosis and at the end of the observation period and on day 8 post application mumifaction of the area of expsoure.

Descriptive scores of the raw data have been converted to Draize numerical scores.

At BASF’s Department of Toxicology, acute toxicity testing was performed according to published methods, which were adapted and standardized for the specific needs of the company, well before Test Guidelines for these methods were established by the OECD beginning 1982. These methods were comparable to the Union Carbide (now a DOW company) range finding toxicity data which have been published in the early toxicological literature (1944-1949). The results of these studies were reported until the early 1980s in summary reports called „Ergebnis der gewerbetoxikologischen Vorprüfung“ or „Toxikologische Grundprüfung“, which do not present details of the methods used, but focus on a summary presentation of the results.

Interpretation of results:
highly corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD guideline or GLP defined, acceptable restrictions (incomplete documentation).
Reason / purpose:
reference to same study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
, only 0.05 mL applied, no 48 and 72 hour observation
Principles of method if other than guideline:
Other: single application of 50 mm³ undiluted test substance into the eye of a rabbit, observation time: 8 d (no further information).
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.25 and 3.43 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: The NaCl-treated adjacent eye served as control.
Duration of treatment / exposure:
Single application of 50 mm³ undiluted test substance into the eye of a rabbit.
Observation period (in vivo):
8 d (scoring at 1 hour, 24 hours and 8 days)
Number of animals or in vitro replicates:
2
Irritant / corrosive response data:
Both treated animals showed corrosion of the eye after 1 h, additionally edema after 24 h and purulence after 8 d. No irritant or corrosive response was observed in the control eyes.

At BASF’s Department of Toxicology, acute toxicity testing was performed according to published methods, which were adapted and standardized for the specific needs of the company, well before Test Guidelines for these methods were established by the OECD beginning 1982. These methods were comparable to the Union Carbide (now a DOW company) range finding toxicity data which have been published in the early toxicological literature (1944-1949). The results of these studies were reported until the early 1980s in summary reports called „Ergebnis der gewerbetoxikologischen Vorprüfung“ or „Toxikologische Grundprüfung“, which do not present details of the methods used, but focus on a summary presentation of the results.

Interpretation of results:
highly corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

Skin irritation was tested using a standard method (BASF AG, 1971). The study meets scientific standards with acceptable restrictions (limited documentation). Two New Zealand White rabbits were treated for1, 5, 15 min and 20 h at the back using a gaze pad (2.5 cm²) and for 20 h in the inner surface of the ear with a cotton ball.The post exposure period was 8 days.Both treated animals showed weak (1 and 5 min) to severe (20 hours) necrosis, with an increasing area of necrosis during the observation period (treatment site back). Severe necrosis and at the end of the observation period and on day 8 post application mumifaction of the area of expsoure were observed at the treatment site ear.

 

In a second study ( Bayer AG, 1977) the test item was tested using as well a standard method. The study meets scientific standards with acceptable restrictions (limited documentation). Two New Zealand White rabbits were treated for 1 and 4 hours. The inner surface of the ear was treated with 500 µL of the undiluted test substance and occlusively covered. After the exposure time the test substance was rinsed with water and soap/plant oil. The post exposure period was 7 days. After the exposure period of 1 or 4 hours intense reddening and moderate swelling of the treated ear region was observed. Also severe corrosion was reported in both animals.

 

Eye irritation:

Eye irritation was tested using a standard method (BASF AG, 1971). The study meets scientific standards with acceptable restrictions (limited documentation). 0.05 mL of the test substance was applied to the conjunctival sac of each one eye of 2 rabbits (Vienna White). Treatment was followed by an observation period of 8 days. Both treated animals showed corrosion of the eye after 1 h, additionally edema after 24 h and purulence after 8 d. No irritant or corrosive response was observed in the control eyes. Thus the test item was highly corrosive to the rabbit eye.

 

In a second study (Bayer AG, 1977) the test item was tested using as well a standard method. The study meets scientific standards with acceptable restrictions (limited documentation). 100 µL of the test substance was applied to the conjunctival sac of each one eye of 2 rabbits (New Zealand White), without washing and an observation period of 7 days. The conjunctiva of the treated animals was completely clouded and weak to severe reddening and swelling of the cornea could be observed at the end of the observation period. Thus the test item was highly corrosive to the rabbit eye.


Justification for selection of skin irritation / corrosion endpoint:
The key study was selected.

Justification for selection of eye irritation endpoint:
The key study was selected.

Effects on skin irritation/corrosion: highly corrosive

Effects on eye irritation: highly corrosive

Justification for classification or non-classification

Benzylamine is currently classified with C;R34 and Skin Corr. 1B according to Directive 67/548/EEC and Regulation (EC) No 1272/2008. This classification is supported by the animal data provided in this section.