Registration Dossier

Administrative data

Description of key information

The test substance is corrosive to the skin and denaturates eye mucous membranes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable study report.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
According to BASF-internal standard, see details in the section "Any other information on materials and methods incl. tables".
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
Mean body weights of the rabbits: 2.85 kg
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal served as control.
Amount / concentration applied:
ca. 1 mL
Duration of treatment / exposure:
3 minutes
Observation period:
8 days
Number of animals:
2
Details on study design:
Application area: 2.5 x 2.5 cm
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: parchment-like necrosis (comprehensive)
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: comprehensive
Irritation parameter:
erythema score
Basis:
animal: #1, #2
Time point:
other: 3 min
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: necrosis observed, overarching skin reaction
Irritation parameter:
edema score
Basis:
animal: #1, #2
Time point:
other: 3 min
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: overarching skin reaction
Other effects:
Pathology: The skin effects of the sacrificed animals were macroscopically confirmed.
Interpretation of results:
highly corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In a skin irritation/corrosion study (BASF, 1980), 2 Vienna White rabbits were treated with undiluted test substance for 3 min using occlusive conditions. An application site of 2.5 cm² was covered with ca. 1 mL of the liquid test substance. The animals were observed for 8 days and skin changes were recorded daily. For a final evaluation, the findings from 24 and 48 hours from the raw data were taken into account on a mean basis (erythema score, edema score). The application for 3 min evoked after 3 min strong skin reactions and caused after 24 hours leathery-like necrosis in both animals. Parchment-like necrosis was observed after 8 days. This study is classified as acceptable. It generally satisfies the guideline requirements for OECD 404.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable study report.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
According to BASF-internal standard, see details in the section "Any other information on materials and methods incl. tables".
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
Mean body weights: 2.99 kg
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
ca. 1 mL
Duration of treatment / exposure:
20 h
Observation period:
8 d
Number of animals:
2
Details on study design:
Application area: 2.5 x 2.5 cm
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(incubation time: 5, 15; skin at the back)
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
other: after 8 days: severe, not relocatable necrosis
Remarks on result:
other: at the edge, in general leathery necrosis
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(incubation time: 20 h; skin at the back)
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days severe, not relocatable necrosis
Remarks on result:
other: at the edge, in general leathery necrosis
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(incubation time: 1 min; skin at the back)
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days, necrosis still present
Remarks on result:
other: at the edge (incl. bleedings), in general necrosis
Interpretation of results:
highly corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In a skin irritation/corrosion study (BASF, 1969), 2 Vienna White rabbits were treated with undiluted test substance for 1, 5, 15 min or 20 hours using occlusive conditions.An application site of 2.5 cm² was covered with ca. 1 mL of the liquid test substance.The animals were observed for 8 days and skin changes were recorded. For a final evaluation, the findings from 24 hours from the raw data were taken into account on a mean basis (erythema score, edema score). After application for 1 min leathery-like necrosis in both animals was observed after 24 hours. Severe, not relocatable necrosis was observed after 8 days.This study is classified as acceptable. It generally satisfies the guideline requirements for OECD 404.

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
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable study report.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
According to BASF-internal standard, see details in remarks on material and methods.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Vehicle:
unchanged (no vehicle)
Controls:
other: he adjacent eye served as saline control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 50 µL
Duration of treatment / exposure:
Single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 hours on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report describes findings after 1 and 24 hours and at the end of the observation period.
Irritation parameter:
other: corrosion
Basis:
mean
Time point:
other: within few minutes
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: Reaction observed shortly after instillation.

Already after a few minutes of the test substance instillation, corrosion of the eyes was observed.

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In this acute eye irritation/corrosion study (BASF, 1969), the eyes of 2 Vienna White rabbits were exposed by application of 50 µL undiluted test substance into the conjunctival sac. The animals were observed after 10 min, 1 and 3 hours on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours. Overall, the treatment caused corrosion of the eye mucous membranes within 1 hour.Thus, the test substance was graded as corrosive under the conditions of this study. This study is classified as acceptable. It satisfies the requirements of OECD test guideline 405.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

In a skin irritation/corrosion study (BASF, 1980), 2 Vienna White rabbits were treated with undiluted test substance for 3 min using occlusive conditions. An application site of 2.5 cm² was covered with ca. 1 mL of the liquid test substance. The animals were observed for 8 days and skin changes were recorded daily. For a final evaluation, the findings from 24 and 48 hours from the raw data were taken into account on a mean basis (erythema score, edema score). The application for 3 min evoked after 3 min strong skin reactions and caused after 24 hours leathery-like necrosis in both animals. Parchment-like necrosis was observed after 8 days. This study is classified as acceptable. It generally satisfies the guideline requirements for OECD 404.

In a further skin irritation/corrosion study (BASF, 1969), 2 Vienna White rabbits were treated with undiluted test substance for 1, 5, 15 min or 20 hours using occlusive conditions. An application site of 2.5 cm² was covered with ca. 1 mL of the liquid test substance. The animals were observed for 8 days and skin changes were recorded. For a final evaluation, the findings from 24 hours from the raw data were taken into account on a mean basis (erythema score, edema score). After application for 1 min leathery-like necrosis in both animals was observed after 24 hours. Severe, not relocatable necrosis was observed after 8 days. This study is classified as acceptable. It generally satisfies the guideline requirements for OECD 404.

Based on observed corrosive effects, the substance has to be judged as highly corrosive to skin.

Eye irritation

 

In an acute eye irritation/corrosion study (BASF, 1969), the eyes of 2 Vienna White rabbits were exposed by application of 50 µL undiluted test substance into the conjunctival sac. The animals were observed after 10 min, 1 and 3 hours on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours. Overall, the treatment caused corrosion of the eye mucous membranes within 1 hour. Thus, the test substance was graded as corrosive under the conditions of this study. This study is classified as acceptable. It satisfies the requirements of OECD test guideline 405.

Justification for classification or non-classification

Based on the results for skin irritation (corrosive) and for eye irritation, the test substance is classified for skin irritation/corrosion as follows:

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the substance is considered to be classified for skin or eye irritation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014, as follows:

Cat. 1A, H314, causes severe skin burns and eye damage; Cat. 1, H318, causes serious eye damage.